FDA Adverse Event
Injury
Summary report: N
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
MDR report key: 1904583
·
Received November 22, 2010
Report
- Report Number
- 3005099803-2010-04865
- Event Type
- Injury
- Date Received
- November 22, 2010
- Report Date
- November 3, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FGE
- PMA / PMN Number
- K924608
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT "THE PATIENT IMPLANTED WITH THIS STENT SHOWED A HYDRONEPHROSIS." MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC - SPENCER | M0061251320 | 13170492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |