MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-11 for MICROVASIVE RF PA30153 * manufactured by Boston Scientific Corp. Microvasive.
[132838]
Microvasive rf pa30153 glidewire lot #8895b09 broke during ureteroscopy procedure. Broken piece retrieved by surgeon under ureteroscopic vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013830 |
| MDR Report Key | 168068 |
| Date Received | 1998-05-11 |
| Date of Report | 1997-01-24 |
| Date of Event | 1997-01-22 |
| Date Added to Maude | 1998-05-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROVASIVE |
| Generic Name | GLIDEWIRE |
| Product Code | EYA |
| Date Received | 1998-05-11 |
| Model Number | RF PA30153 |
| Catalog Number | * |
| Lot Number | 8895B09 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 163532 |
| Manufacturer | BOSTON SCIENTIFIC CORP. MICROVASIVE |
| Manufacturer Address | 1 BOSTON SCIENTIFIC PL. NATICK MA 017601537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-11 |