FDA Adverse Event
Malfunction
Summary report: N
ROTAWIRE
MDR report key: 2073509
·
Received April 21, 2011
Report
- Report Number
- 2073509
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- October 18, 2010
- Report Date
- April 12, 2011
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
- Product Code
- MCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
Narratives
Description of Event or Problem · 1
DURING A CARDIAC CATH PROCEDURE, A FRACTURE OF THE BOSTON SCIENTIFIC ROTAWIRE WAS DETECTED UNDER FLUOROSCOPY. THE WIRE WAS REMOVED AND A SECOND WIRE WAS UTILIZED. THE TIP OF THE 2ND WIRE WAS FOUND TO BE DEFECTIVE WHEN THE TIP OF THE WIRE BROKE OFF. STAFF VERIFIED UNDER FLUOROSCOPY THAT THE BROKEN WIRE TIP WAS NOT IN THE PATIENT AND STAFF ACKNOWLEDGED THAT THE TIP FELL TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTAWIRE | ROTAWIRE W/ WIRE CLIP TORQUER | MCW | BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY | * | 1348241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | NO OTHER THERAPIES |