MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-23 for COOK HIGH-FLO TORQUE CONTROL COBRA VISCERAL CATHETER HBP manufactured by Cook Group.
[1781]
Aortobifemoral bypass graft performed prior to 11/4/92; arterogram performed 11/4/92. No damage to catheter, and no complications were noted. Ultrasonic evaluation performed 12/16/92, on a mass in the right groin. Results indeterminate. Surgery performed on 12-17-92. Foreign body removed, and identified as pieces of a catheterdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2500 |
| MDR Report Key | 2500 |
| Date Received | 1993-02-23 |
| Date of Event | 1992-11-04 |
| Date Facility Aware | 1992-12-17 |
| Date Reported to Mfgr | 1993-01-26 |
| Date Added to Maude | 1993-03-10 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK HIGH-FLO TORQUE CONTROL COBRA VISCERAL CATHETER |
| Generic Name | ANGIOGRAPHIC CATHETER |
| Product Code | FGI |
| Date Received | 1993-02-23 |
| Model Number | HBP |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2325 |
| Manufacturer | COOK GROUP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-23 |