MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-01 for DOUBLE PIGTAIL STINT 7 X 24 manufactured by Cook Urological, Inc..
[2160]
The surgeon attempted to remove the urological stint. During the procedure, approximately half of the stint broke off, remaining in the patient. Aguide wire was in use at the timedevice 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. No 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, visual examination. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3843 |
| MDR Report Key | 3843 |
| Date Received | 1993-02-01 |
| Date of Report | 1992-12-28 |
| Date of Event | 1992-12-22 |
| Date Facility Aware | 1992-12-22 |
| Report Date | 1992-12-28 |
| Date Reported to FDA | 1992-12-28 |
| Date Reported to Mfgr | 1992-12-22 |
| Date Added to Maude | 1993-05-06 |
| 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 | DOUBLE PIGTAIL STINT |
| Product Code | MER |
| Date Received | 1993-02-01 |
| Catalog Number | 7 X 24 |
| Lot Number | 0912358 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3583 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-02-01 |