FDA Adverse Event
Malfunction
Summary report: N
ARCHER GUIDEWIRE
MDR report key: 2912323
·
Received January 11, 2013
Report
- Report Number
- 2953200-2013-00079
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Report Date
- December 14, 2012
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- DQX
- PMA / PMN Number
- K101339
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS AND CONCLUSIONS: LACK OF INFORMATION (UNKNOWN CAUSE OF INCOMPATIBILITY ISSUE).
Description of Event or Problem · 1
AN ARCHER GUIDEWIRE WAS USED AS AN ACCESSORY PRODUCT IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT WHEN THE ARCHER WIRE IS INSERTED IN ANOTHER MANUFACTURER'S PIGTAIL CATHETER, THE WIRE HAS A TENDENCY TO GET STUCK IN THE PIGTAIL CATHETER DURING REMOVAL. IT WAS REPORTED THAT THE PHYSICIAN HAS EXPERIENCED THIS IN TWO PREVIOUS OCCASIONS. THE CUSTOMER USED ANOTHER MANUFACTURER'S WIRES. THIS IS MOST PRESENT WHEN THEY ARE USING ARCHER TOGETHER WITH CORDIS PIGTAIL WITH MARKERS. THE ARCHER WIRE WAS DISCARDED. NO CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16267 | ARCHER GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | MEDTRONIC CARDIOVASCULAR | GFVG0633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |