MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-12-09 for DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM 48409 manufactured by Medtronic Neurosurgery.
[5135827]
It was reported to medtronic neurosurgery that during a vp shunt implantation surgery, the tip of the disposable catheter passer broke off. The tip was left within the patient and the surgery was completed without delay. It was also reported that the patient has not experienced any adverse effects due to the event.
Patient Sequence No: 1, Text Type: D, B5
[12502383]
The tip was observed to be missing from the end of the returned catheter passer? S obturator. Some evidence of plastic stressing was observed at the break site. It is unknown how or when the damage occurred. A review of the manufacturing records showed no anomalies. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2014-00484 |
| MDR Report Key | 4308774 |
| Report Source | 01,05 |
| Date Received | 2014-12-09 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Device Manufacturer Date | 2014-09-25 |
| Date Added to Maude | 2014-12-17 |
| 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 | 0 |
| Event Location | 0 |
| 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, 60CM |
| Generic Name | CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM |
| Product Code | MAJ |
| Date Received | 2014-12-09 |
| Returned To Mfg | 2014-11-21 |
| Catalog Number | 48409 |
| Lot Number | D67324 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2014-12-09 |