CYTOSPONGE CELL COLLECTION DEVICE CYTO-KITR

[42260175] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[42260176] Customer reported that during a cytosponge procedure the sponge detached from the suture. The subject swallowed the capsule without difficulty. The sponge remained in the stomach for 7 minutes.. When the physician pulled on the string to retrieve the sponge, the string became detached from the sponge. Upon inspection, the loop and knot are still intact. The patient was assessed for pain with a vas score of 006. The patient did not have any difficulty breathing and was not in any distress. Physician proceeded with planned endoscopy and biopsy. There were no abrasions found in the mouth, throat, or gej. The sponge was found within the (1-2 cm) hiatal hernia sac above the nissen fundoplication. Endoscopic findings were consistent with normal post-operative anatomy. Grade ii mucosa trauma was seen where the capsule was found. The sponge was retrieved with a biopsy forcep and pushed back into the stomach where it was captured using a net, there was no difficulty pulling the sponge up through the esophagus. Patient has been discharged.
Patient Sequence No: 1, Text Type: D, B5

[55050193] Manufacture reference number: (b)(4). Evaluation summary: one used device was received for evaluation. The customer reported the suture became detached from the sponge. The reported condition was confirmed. The visual inspection found the sponge and suture were received separately. The sponge was received in a specimen jar and the suture was received in a bio-hazard bag. The investigation found visually, the suture had torn through the sponge. The investigation isolated the failure to the suture tearing through the sponge, but a root cause was not identified. A review of the device history records for the provided lot/serial number was completed and no entries pertinent to the event were noted and this lot/serial number was released meeting all specifications as manufactured.
Patient Sequence No: 1, Text Type: N, H10

[64146312] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[64146313] Based on additional information, there is a definite relationship to device but it is not related to the endoscopy procedure. It is considered a serious adverse event but it was not an unanticipated adverse device effect.
Patient Sequence No: 1, Text Type: D, B5