FDA Adverse Event
Malfunction
Summary report: N
BALANCE MIDDLEWEIGHT GUIDEWIRE
MDR report key: 17531356
·
Received August 12, 2023
Report
- Report Number
- MW5138271
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 20, 2022
- Manufacturer
- ABBOTT
- Product Code
- DQX
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A GUIAE WIRE WAS USED TO PLACE THE 1EAA . WHEN THE WIRE'S PULLED BACK INTO THE LEAD, THE WIRE IN THE LEAD IS TORN OFF. GUIDE WIRE: ABBOTT, BALANCE MIDDLEWEIGHT 0.014" 190CM REF:(B)(4) LOT:1082373 UBD:2023-07-31 604835220 THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727818 | BALANCE MIDDLEWEIGHT GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | ABBOTT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |