FDA Adverse Event
Injury
Summary report: N
SENSOR¿
MDR report key: 2933197
·
Received January 29, 2013
Report
- Report Number
- 3005099803-2013-00200
- Event Type
- Injury
- Date Received
- January 29, 2013
- Report Date
- January 7, 2013
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- EZB
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ULTRASOUND PROCEDURE, THE TIP OF THE SENSOR GUIDEWIRE WAS NOTICED TO BE BROKEN OFF AND INSIDE THE KIDNEY. IT IS UNKNOWN IF THE TIP OF THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. IT IS ALSO NOT KNOWN IF A SECOND PROCEDURE WAS SCHEDULED FOR REMOVAL.ADDITIONAL ATTEMPTS HAVE BEEN MADE TO OBTAIN EVENT CLARIFICATION AND PATIENT FOLLOW UP. THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39623 | SENSOR¿ | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M0066703081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |