MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for COOK CXI-2.6-18-90-P-NS- G5002 manufactured by Cook Medical.
[65003157]
During the procedure in the right pedal area, they were withdrawing the catheter and wire (cxi 018 x90) and the tip broke off in the pt. The md was unable to retrieve it and had to take the pt to surgery for a r below knee popliteal to dorsalis pedis artery bypass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067200 |
| MDR Report Key | 6249113 |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-06 |
| Date of Event | 2017-01-04 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK |
| Generic Name | CXI SUPPORT CATHETER |
| Product Code | GCE |
| Date Received | 2017-01-11 |
| Model Number | CXI-2.6-18-90-P-NS- |
| Catalog Number | G5002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-11 |