MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-04 for CATHETER PASSER, DISPOSABLE, 60 CM 48409 manufactured by Medtronic Neurosurgery.
[132216960]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132216961]
It was reported there were? Several instances? Of the catheter passer breaking over the? Past year.? The part that was breaking was the part where the catheter is attached to the end of the obturator. It was stated this would sometimes occur when detaching that end of the obturator from the catheter passer handle. The neurosurgeon would either replace the product or make use of the current passer. There were no injuries associated with the issue. The passers were discarded and not available for return. No further specific event, patient, or device information was available for the reported instances.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2019-00007 |
| MDR Report Key | 8219324 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-04 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| 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 | CATHETER PASSER, DISPOSABLE, 60 CM |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2019-01-04 |
| Model Number | 48409 |
| Catalog Number | 48409 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-01-04 |