MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-23 for NEPHROWETERAL STENT manufactured by Boston Scientific Corporation.
[152177502]
Placing a nephroureteral stent due to calcification within the kidney. While in the proper location for deployment, trying to put the inner stylet and wire out, the locking cap and plastic stylet both broke. Physician was able to retrieve and remove broken pieces. A different tube / stent was used to complete the procedure. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5088310 |
| MDR Report Key | 8821928 |
| Date Received | 2019-07-23 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-07-17 |
| Date Added to Maude | 2019-07-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEPHROWETERAL STENT |
| Generic Name | STENT, RENAL |
| Product Code | NIN |
| Date Received | 2019-07-23 |
| Lot Number | 22748398 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-23 |