FDA Adverse Event
Malfunction
Summary report: N
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDR
MDR report key: 1766819
·
Received July 20, 2010
Report
- Report Number
- 2024168-2010-01454
- Event Type
- Malfunction
- Date Received
- July 20, 2010
- Date of Event
- June 25, 2010
- Report Date
- June 25, 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
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE BALANCE MIDDLEWEIGHT GUIDE WIRE PART # 1001780S-HC/LOT# 0042671 IS BEING FILED UNDER A SEPARATE MFR#.
Description of Event or Problem · 1
DEVICE ISSUE: SEPARATED GUIDE WIRE TIP. TIME OF DEVICE ISSUE: DURING UNPACKING/DURING PROCEDURE. ADVERSE EVENT: NONE REPORTED. IT WAS REPORTED THAT DURING UNPACKING OF THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE, THE TIP OF THE GUIDE WIRE WAS FOUND SEPARATED. A SECOND BMW GUIDE WIRE WAS USED AND DURING THE PROCEDURE, WHILE BEING PULLED, THE GUIDE WIRE BROKE AND THE TIP OF THE GUIDE WIRE SEPARATED. THERE WAS NO REPORT OF INTERVENTION AND THE DEVICE WAS REMOVED FROM THE PT WITH NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.
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 | 0042271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | LOT# 0042671| BALANCE MIDDLEWEIGHT GUIDE WIRE PART#1001780S-HC |