MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-24 for CATHETER PASSER, DISPOSABLE, 60 CM 48409 manufactured by Medtronic Neurosurgery.
[118110303]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118110304]
It was reported that during the procedure, the sharp tip of the catheter passer broke. It was stated that there was a surgical delay of about 20 minutes to remove the part which was left in the body. No broken pieces remained in the patient? S body following the procedure and there was no injury to the patient. The procedure was completed with backup products.
Patient Sequence No: 1, Text Type: D, B5
[126657875]
The obturator was returned inside the aperture of the passer shaft (excluding the bullet-shaped obturator tip). The passer shaft, including the obturator inside, were not returned straight but bent into a semi-circle. The bullet-shaped obturator tip was broken off from the rest of the obturator and sent in a separate zip-lock bag. The product was removed from the packaging, and the broken part of the obturator was removed from the passer shaft for inspection. The obturator tip was broken off from the obturator and appeared to have damage to the silicone. It is not known how, or when this damage occurred. The ifu cautions in the? Warnings and precautions? Section that,? Improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.? No other unusual characteristics were noted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2018-00422 |
| MDR Report Key | 7812544 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-24 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-08-24 |
| 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 | 2018-08-24 |
| Returned To Mfg | 2018-09-05 |
| Model Number | 48409 |
| Catalog Number | 48409 |
| Lot Number | UNKNOWN |
| 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 | 2018-08-24 |