MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-23 for CARDIOVASCULAR CATHETER JR 4 7F 100CM 006519 manufactured by Cr Bard, Inc..
[22186299]
The patient was undergoing a heart catherization. At 1000 he had an onset of chest pain. At 1001 the catheter was removed less the distal 10cm which had broken off and remained lodged in the right iliac or femoral artery region. Shortly thereafter the distal 10cms of catheter was retrieved from the right femoral artery. The patient was pronounced dead at 1100. The broken catheter was felt to be incidental to the deathdevice 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 used as labeled/intended. 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: no. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 762 |
| MDR Report Key | 762 |
| Date Received | 1992-06-23 |
| Date of Report | 1992-06-05 |
| Date of Event | 1992-05-26 |
| Date Facility Aware | 1992-05-26 |
| Report Date | 1992-06-05 |
| Date Reported to FDA | 1992-06-05 |
| Date Reported to Mfgr | 1992-06-05 |
| Date Added to Maude | 1992-06-25 |
| 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 | CARDIOVASCULAR CATHETER |
| Generic Name | POSITROL II, TAPERED TIP, JUDKINS RIGHT 4CM CURVE |
| Product Code | LFK |
| Date Received | 1992-06-23 |
| Model Number | JR 4 7F 100CM |
| Catalog Number | 006519 |
| Lot Number | 09 CC 1383 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 747 |
| Manufacturer | CR BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-06-23 |