MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-23 for COOK UNK manufactured by Cook Medical.
[937462]
Using sterile seldinger technique, a 16 fr chest tube was being inserted into the left chest of the pt. As the dilators were being used to enlarge the entry site over the wire, the wire was noted to be frayed and unwinding. The wire was removed from the pt, in total, and a new kit was used to complete the procedure successfully. No adverse outcome was noted for the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1179624 |
| MDR Report Key | 1179624 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-08-05 |
| Date Facility Aware | 2008-08-05 |
| Report Date | 2008-08-14 |
| Date Reported to Mfgr | 2008-08-14 |
| Date Added to Maude | 2008-10-01 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK |
| Generic Name | GUIDEWIRE |
| Product Code | GBW |
| Date Received | 2008-09-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1208585 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | * BLOOMINGTON IN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-23 |