FDA Adverse Event
Malfunction
Summary report: N
FOGARTY GRAFT THROMBECTOMY CATHETER
MDR report key: 1896778
·
Received November 10, 2010
Report
- Report Number
- 2015691-2010-14347
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- EDWARDS LIFESCIENCES PR
- Product Code
- MCW
- PMA / PMN Number
- K942457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE LIGHT PURPLE ADAPTOR IS BROKEN AT THE BOND SITE, WHERE IT IS BONDED TO THE WHITE SHIPPING TUBE. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE ADAPTOR CAP AND THE OTHER AROUND THE DIRECTIONS FOR USE (DFU). ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED, THERE IS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. IT APPEARS THAT THE COMPROMISED PACKAGING TUBE OCCURRED SOMETIME AFTER PRODUCTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PACKAGE WAS RECEIVED THE PACKAGE WAS DAMAGED AND GRAFT THROMBECTOMY CATHETER WAS UNSTERILE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY GRAFT THROMBECTOMY CATHETER | GRAFT THROMBECTOMY CATHETER | MCW | EDWARDS LIFESCIENCES PR | 160246F | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |