FDA Adverse Event
Malfunction
Summary report: N
GUARDWIRE 3-6 200CM RX
MDR report key: 494357
·
Received November 3, 2003
Report
- Report Number
- 1220452-2003-00136
- Event Type
- Malfunction
- Date Received
- November 3, 2003
- Date of Event
- October 31, 2003
- Report Date
- October 31, 2003
- Manufacturer
- MEDTRONIC VASCULAR, INC.
- Product Code
- NFA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PREPARATION OF THE GUARDWIRE WENT SMOOTHLY WITHOUT ANY ISSUES. PRIOR TO PASSING THE GUARDWIRE, PRE-DILATATION WITH A 2.0 X 30MM STORMER BALLOON WAS PERFORMED, VASCULATURE INTERFERENCE DID NOT APPEAR TO BE AN ISSUE. WHILE CROSSING THE WIRE IT WAS NOTED THAT THE DISTAL SEGMENT FRACTURED. UPON REMOVAL, THE DISTAL TIP/BALLOON REMAINED IN THE PATIENT WHERE IT WAS STENTED AGAINST THE VESSEL, IT DID NOT PERFORATE THE VESSEL AND THE PATIENT IS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDWIRE 3-6 200CM RX | DISTAL PROTECTION DEVICES | NFA | MEDTRONIC VASCULAR, INC. | NA | 122982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |