MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for AMPLATZ SUPER STIFF GUIDEWIRE 46523 manufactured by Boston Scientific Corporation.
[173505027]
Guidewire unraveled during use. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091962 |
| MDR Report Key | 9538940 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-18 |
| Date Added to Maude | 2020-01-02 |
| 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 | 3 |
| Brand Name | AMPLATZ SUPER STIFF GUIDEWIRE |
| Generic Name | STYLET FOR CATHETER, GASTRO-UROLOGY |
| Product Code | EZB |
| Date Received | 2019-12-31 |
| Catalog Number | 46523 |
| Lot Number | 23745950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-31 |