FDA Adverse Event
Malfunction
Summary report: N
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
MDR report key: 3233007
·
Received July 18, 2013
Report
- Report Number
- 2024168-2013-04506
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 26, 2013
- Manufacturer
- AV-TEMECULA-CT
- Product Code
- DQX
- PMA / PMN Number
- K013833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- QA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF OCCURRENCE ESTIMATED. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
Additional Manufacturer Narrative · 1
(B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO USE THE BALANCE MIDDLEWEIGHT GUIDE WIRE KINKED AND SEPARATED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335711 | ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | GUIDE WIRE | DQX | AV-TEMECULA-CT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |