FDA Adverse Event
Malfunction
Summary report: N
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDR
MDR report key: 1834535
·
Received September 9, 2010
Report
- Report Number
- 2024168-2010-01887
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- August 12, 2010
- Report Date
- August 16, 2010
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- DQX
- PMA / PMN Number
- K013833
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER DEVICE REMOVAL FROM THE ANATOMY, THE BALANCE MIDDLEWEIGHT GUIDE WIRE (BMW) TIP APPROX 15 CM FROM THE TIP TO THE MIDDLE SECTION WAS DAMAGED AND THE COILS WERE SEPARATED. THERE WAS NO REPORTED PT EFFECT. NO ADDITIONAL INFO PROVIDED. DURING DEVICE ANALYSIS IT WAS FOUND THAT THE SHAPING RIBBON WAS SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDR | DQX | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 0052571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |