MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-09 for SV-5 WIRE 503-558X * manufactured by Cordis Corporation.
[4575513]
Once access was made into the right femoral artery an angiography catheter was inserted and the cordis sv-5 guide wire was inserted. The interventionalist was manipulating the wire up through the femoral artery toward the right axillary artery that was noted to have a total occlusion. (the patient's psh included a prior stent placed in the right axillary artery. ) the md noticed on flouro that one of the threads of the guide wire had unraveled. The wire was removed intact without incidence. The wire was placed in a biohazard bag and retained by the department director. The manufacturer's rep was called and made aware of the incident. The wire will be returned to the rep. ======================manufacturer response for interventional guide wire, sv-5 wire (per site reporter). ======================manufacturer's rep, jamie kauffman, 954-654-0707, was contacted by ccl and made aware of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3937386 |
| MDR Report Key | 3937386 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-07-01 |
| Report Date | 2014-07-03 |
| Date Reported to FDA | 2014-07-09 |
| Date Reported to Mfgr | 2014-07-16 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SV-5 WIRE |
| Generic Name | GUIDEWIRE, CATHETER, STEERABLE |
| Product Code | NDQ |
| Date Received | 2014-07-09 |
| Model Number | 503-558X |
| Catalog Number | * |
| Lot Number | 35220722 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 6500 PASEO PADRE PKWY FREMONT CA 94555 US 94555 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-09 |