MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM 48407 manufactured by Medtronic Neurosurgery.
[28075605]
The product was not returned. Therefore an evaluation of device performance was not possible. A review of the manufacturing records showed no anomalies. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28075606]
It was reported to medtronic neurosurgery that the tip of the catheter passer was damaged during the procedure, and the broken part remained in the patient's body. According to the report, the physician determined that the broken piece did not pose a risk to the patient and was not likely to result in injury. Reportedly, the patient is currently under follow-up.
Patient Sequence No: 1, Text Type: D, B5
[31970489]
The catheter passer was returned. The proximal end of the obturator tip was broken off. The break had an uneven, jagged edge. It is unknown how or when this damage occurred. The instructions for use that accompany the device caution? Subcutaneous catheter passers can break at welds or component assembly points, or due to extreme deformation of the malleable shaft. A review of the manufacturing records showed no anomalies. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94850996]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2015-00394 |
| MDR Report Key | 5138618 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-11-03 |
| Device Manufacturer Date | 2014-02-17 |
| Date Added to Maude | 2015-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2015-10-08 |
| Returned To Mfg | 2015-10-05 |
| Catalog Number | 48407 |
| Lot Number | D55640 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |