FDA Adverse Event
Malfunction
Summary report: N
KINETIX¿
MDR report key: 2231780
·
Received September 1, 2011
Report
- Report Number
- 2134265-2011-03741
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Report Date
- August 10, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- DQX
- PMA / PMN Number
- K081021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE 185CM KINETIX GUIDE WIRE WAS CHOSEN FOR THE PROCEDURE. THE WIRE WAS BEING SHAPED AT THE BACK TABLE, OUTSIDE THE PATIENT, WHEN THE TIP BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETIX¿ | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - MAPLE GROVE | H74939122010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |