MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for CATHETER PASSER, DISPOSABLE, 38 CM 48407 manufactured by Medtronic Neurosurgery.
[70820648]
Patient Sequence No: 1, Text Type: N, H10
[70820649]
While the dr. Was using the "shunt passer" to pass the tubing that holds the shunt catheter from the abdomen to the skull, he noticed the tip of the shunt passer had broken off. He presumed that it broke off somewhere along the track from the abdomen to the skull inside the patient. He attempted multiple times to palpate, search the wounds, and also had a second dr's help to use ultrasound to search for the missing piece. It could not be found. They proceeded to finish the case as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431590 |
| MDR Report Key | 6431590 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-08 |
| Date of Event | 2016-11-17 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER PASSER, DISPOSABLE, 38 CM |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | GYK |
| Date Received | 2017-03-24 |
| Model Number | 38 CM |
| Catalog Number | 48407 |
| Lot Number | E16643 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |