BARRX CYTO-KIT-R

[77281032] A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[77281033] According to the reporter, during the required training on cytosponge administration, a healthy volunteer swallowed the sponge without difficulty. During withdrawal of the sponge, the physician had removed? About half of the string length,? When he felt the string? Gave way.? The remainder of the string was removed and appeared to have detached from the sponge. Prior to the detachment of the string from the sponge, the withdrawal process proceeded normally and did not require unusual force or tension on the string. The volunteer relayed no pain or distress, although she did note the sensation that something was in her esophagus, which she was able to localize to the chest, along the mid-esophagus. She remained without significant symptoms and was immediately moved to the endoscopy suite. An esophagogastroduodenoscopy (egd) was performed without difficulty. The sponge was noted to be located in the stomach and was removed with a snare. During the egd, mild abrasions at the distal end of the gastroesophageal junction (gej) and distal esophagus were noted, which he the physician viewed as an expected finding when the sponge moves through the lower esophageal sphincter (les). He noted no other abnormalities in the stomach or esophagus. Based on the noted abrasions along the gej, the length of string that had been removed prior to detachment, and the patient? S report of a sensation along the chest, the physician suspected that the sponge passed through the gej without detaching and then detached more proximal in the esophagus, perhaps even at the level of the cricopharyngeal muscle. He believes that normal peristalsis then moved the sponge back to the stomach prior to the egd. Healthy volunteers who participate in the standardized cytosponge training process do not normally receive an egd after cytosponge administration. However, the risk of sponge detachment and need for egd should a detachment occur, as was required in this case, is described in the healthy volunteer consent form. The volunteer did not undergo unintended radiation exposure (xrays, ct scans, mris, etc). The patient did not have any unanticipated blood loss and the procedure time was not delayed by more than 30 minutes do to the product problem. No other known adverse events were reported. [regarding the sentence,? The device fragment did fall into the patient cavity?.? , i would suggest removing or rephrasing if possible. I don? T believe the gastrointestinal tract (beyond the oral cavity) is typically referred to as a? Cavity.? If possible to rephrase, consider? The detached sponge was retained in the esophagus and was removed via egd.? Additional information received as follows; on (b)(6) 2017 the nurse supervisor reported the following. The volunteer was given approximately 240-300 cc of water when administering the capsule. It appeared that the capsule when down smoothly. The patient held the plastic card the string was attached to once the capsule was swallowed. The patient talked very minimally during the period of time the capsule was ingested. From the time it was acknowledged, the capsule was down, 7 minutes and 30 seconds had passed before attempting to retrieve the capsule. Additional information received as follows; medtronic medical affairs spoke to the physician who administered the sponge on (b)(6) 2017. No unusual procedure events occurred such as difficulty swallowing sponge, unusual pain with retrieval or bleeding. There were no unusual findings on the endoscopy, such as small diameter proximal esophagus, non-complaint ues, stenosis or esophageal narrowing. There were no deviations from standard ingestion and retrieval protocol other than the following; on first ingestion attempt (which did not detach), the string was "gathered in an accordion style" between two fingers prior to placement in the patients mouth. During the second ingestion (which did detach), the string was "gathered by wrapping around a finger" before being placed into the patients mouth. It appeared gentle traction was applied to the string upon retrieval; no unusual force was required upon removal (compared to the first). There were no abrupt changes in the rate of pull. The string appeared to be intact; including the knot, but no sponge material was attached. Upon endoscopic retrieval, the sponge appeared to be intact. The volunteer was discharged in good condition. The physician has communicated with the patient since discharge and is reported to be "doing fine. " additional information received as follows on may 25, 2017: there was nothing unusual about the procedure such as difficulty swallowing sponge and no pain with retrieval. There was the typical tug on the string as the string and sponge passed the ues probably at the level of the cricropharyngeal muscle where the string broke off the sponge. During egd to retrieve sponge, there was no stricture at les or ues. There was erythema and erosions at ge junction from the sponge. The break of the detachment could be felt at the level of the cricropharyngeal muscle. There wasn't a sound when the string detached from the sponge. The physician felt a sudden decrease in the back pressure as the sponge was coming in through the ues. There was no past medical history from the patient. During retrieval, there was a consistent constant pull on the sponge during retrieval and no change in speed or force as sponge was coming up through esophagus.
Patient Sequence No: 1, Text Type: D, B5

[108535042] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[108540570] Investigation summary: one used cyto-kit-r was received for evaluation. The customer reported the sponge detached from the string. The reported condition was confirmed. The visual inspection found the sponge had separated from the suture. The customer reported the sponge detached from the string. The reported condition was confirmed. The investigation isolated the failure to the suture slipping through the sponge while breaking or cutting the struts of the sponge, but a root cause was not identified. No corrective action is required. Trending is performed per local procedure. A review of the device history records for the provided lot/serial number was completed and acceptance criteria for entries potentially pertinent to the customer? S report were within specified limits at the time of release. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10