FDA Adverse Event
Malfunction
Summary report: N
TRANSEND EX 014/205 PLATINUM
MDR report key: 6274913
·
Received January 24, 2017
Report
- Report Number
- 3004859241-2017-00003
- Event Type
- Malfunction
- Date Received
- January 24, 2017
- Date of Event
- December 23, 2016
- Report Date
- March 28, 2017
- Manufacturer
- BOSTON SCIENTIFIC COSTA RICA
- Product Code
- DQX
- UDI-DI
- 08714729326267
- PMA / PMN Number
- K971254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE EXACT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE IS NOT AVAILABLE.
Description of Event or Problem · 1
DURING THE PROCEDURE UPON INSERTION OF THE WIRE INTO THE MICROCATHETER, THE GUIDEWIRE BROKE.
Description of Event or Problem · 1
DURING THE PROCEDURE UPON INSERTION OF THE WIRE INTO THE MICROCATHETER THE GUIDEWIRE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56564 | TRANSEND EX 014/205 PLATINUM | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC COSTA RICA | 18999941 | 08714729326267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MICROCATHETER (UNKNOWN MANUFACTURER) |