FDA Adverse Event
Malfunction
Summary report: N
STONETOME¿
MDR report key: 6979993
·
Received October 26, 2017
Report
- Report Number
- 3005099803-2017-03198
- Event Type
- Malfunction
- Date Received
- October 26, 2017
- Report Date
- October 1, 2017
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- LQR
- PMA / PMN Number
- K946358
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OF THE 5 EVENTS RELATED TO E 2012065, 4 WERE RETURNED AND EVALUATED. ALL 4 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT. ONE OF THE DEVICES WAS DISPOSED AND NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E 2012065 FOR PRODUCT CODE LQR. THIS REPORT SUMMARIZES 5 EVENTS REPORTED TO BOSTON SCIENTIFIC FOR STONETOME WIRE BREAKS. OF THE EVENTS, ONE PATIENT WAS REPORTED TO BE MALE AND (B)(6) YEARS OF AGE. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760421 | STONETOME¿ | DISLODGER, STONE, BILIARY | LQR | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M00535150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |