FDA Adverse Event
Malfunction
Summary report: N
ARCHER GUIDEWIRE
MDR report key: 2973076
·
Received February 21, 2013
Report
- Report Number
- 2953200-2013-00314
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 28, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- DQX
- PMA / PMN Number
- K101339
- Removal / Correction Number
- Z-1017-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: LACK OF INFORMATION (CAUSE OF EVENT IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE OF EVENT IS UNKNOWN).
Additional Manufacturer Narrative · 1
DUE TO THE MANUFACTURING RELATED ISSUE, AFFECTED PRODUCT RECALLED UNDER Z-1017-2013.
Description of Event or Problem · 1
AN ARCHER GUIDEWIRE WAS USED AS ACCESSORY PRODUCTS IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT AFTER REMOVING THE GUIDEWIRE FROM THE PATIENT A NURSE NOTICED WHILE DURING ROLLING IT UP THAT THE PTFE COATING SEPARATED FROM THE STEEL CORE OF THE WIRE. THIS WAS NOTED WITH ONE OF TWO WIRES THAT WERE USED IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76521 | ARCHER GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | MEDTRONIC CARDIOVASCULAR | GFWA0387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |