MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-11 for GUGLIELMI DETACHABLE COIL 350045 (PRODUCT #) UNKNOWN manufactured by Target Therapeutics.
[16268700]
The patient was undergoing right internal carotid aneurysm repair. A 5 x 30 mm tracker 18 coil was being manipulated for optimal positioning when it was identified that the wire had broken within the catheter. Device labeled for single use. Patient medical status prior to event: unknown. 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. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7537 |
| MDR Report Key | 7537 |
| Date Received | 1994-01-11 |
| Date of Report | 1993-09-20 |
| Date of Event | 1993-09-20 |
| Date Facility Aware | 1993-09-20 |
| Report Date | 1993-09-20 |
| Date Added to Maude | 1994-04-29 |
| 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 | GUGLIELMI DETACHABLE COIL |
| Generic Name | COIL |
| Product Code | FKD |
| Date Received | 1994-01-11 |
| Model Number | 350045 (PRODUCT #) |
| Catalog Number | UNKNOWN |
| Lot Number | A12240 |
| ID Number | 5 MM HELIX/30/T18 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7216 |
| Manufacturer | TARGET THERAPEUTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-11 |