MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-03 for MARDIS SOFT HYDROPLUS COATED URETERAL STENT SET 6F X 26 CM 548872-08 125-133 manufactured by Microvasive Boston Scientific Corporation.
[17763208]
Patient had left ureteral stent placed 1/13/92 for hydronephrosis. Patient returned to surgery on 1/28/92 for removal of the stent. During the removal the stent broke leaving approximately 1/3/ in the pelvis of the left kidney. Patient returned to surgery on 2/6/92 for removal of retained stent. This removal was accomplished by ureteroscope. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3719 |
| MDR Report Key | 3719 |
| Date Received | 1992-08-03 |
| Date of Event | 1992-01-28 |
| Date Facility Aware | 1992-02-04 |
| Date Reported to Mfgr | 1992-02-18 |
| Date Added to Maude | 1993-05-03 |
| 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 | MARDIS SOFT HYDROPLUS COATED URETERAL STENT SET 6F X 26 CM |
| Generic Name | URETERAL STENT SET |
| Product Code | MER |
| Date Received | 1992-08-03 |
| Model Number | 548872-08 |
| Catalog Number | 125-133 |
| Lot Number | H47067 |
| Device Expiration Date | 1995-12-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3465 |
| Manufacturer | MICROVASIVE BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-03 |