MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-01-10 for PERIT R/C CATHETER STRIPED * NL850-1375 manufactured by Integra Neurosciences Pr.
[552069]
The distributor reported on behalf of the user facility the following incident: the csf did not flow smoothly in the shunt system. A revision was performed. The physician checked the removed shunt system and found three (3) clots in the peritoneal catheter. The clots were observed at about five (5) centimeter intervals from the tip of the catheter.
Patient Sequence No: 1, Text Type: D, B5
[8056011]
To date the device has not been received for evaluation. Additional information has been requested. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648988-2007-00001 |
| MDR Report Key | 804686 |
| Report Source | 08 |
| Date Received | 2007-01-10 |
| Date of Report | 2007-01-02 |
| Date Mfgr Received | 2006-12-12 |
| Date Added to Maude | 2007-01-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DANIEL-GARY HOLDERMAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES, PR |
| Manufacturer Street | STATE ROAD 402, KM 1.2 P.O. BOX 167 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIT R/C CATHETER STRIPED |
| Generic Name | CSF PRODUCTS |
| Product Code | GBW |
| Date Received | 2007-01-10 |
| Model Number | * |
| Catalog Number | NL850-1375 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 792184 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | * ANASCO PR * US |
| Baseline Brand Name | PERITONEAL REFLUX CONTROL CATHETER |
| Baseline Generic Name | PERITONEAL CATHETER |
| Baseline Model No | NL850-1375 |
| Baseline Catalog No | NL850-1375 |
| Baseline ID | * |
| Baseline Device Family | PERITONEAL CATHETER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NI |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-10 |