FDA Adverse Event
Malfunction
Summary report: N
ACS HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING
MDR report key: 176908
·
Received July 9, 1998
Report
- Report Number
- 2024168-1998-00284
- Event Type
- Malfunction
- Date Received
- July 9, 1998
- Date of Event
- April 12, 1998
- Report Date
- June 10, 1998
- Manufacturer
- GUIDANT ACS/DVI
- Product Code
- DQX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP COIL OF GUIDE WIRE WAS NOTED TO BE STRETCHED AND THE SHAPE WAVY WHEN REMOVED FROM THE PACKAGE. ANALYSIS OF THE RETURNED GUIDE WIRE REVEALED THAT THE CORE HAD SEPARATED. THE PRODUCT WAS NOT USED ON A PT. THIS IS BEING FILED AS AN MDR BASED ON CO'S INVESTIGATIVE FINDINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING | GUIDE WIRE | DQX | GUIDANT ACS/DVI | NA | 7121351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |