FDA Adverse Event
Malfunction
Summary report: N
HS III PROXIMAL SEAL SYS 4.3MM
MDR report key: 3960110
·
Received June 23, 2014
Report
- Report Number
- 2242352-2014-00711
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Report Date
- May 28, 2014
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE REPORTED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THE SEAL ON THE HEARTSTRING WOULD NOT CRIMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364780 | HS III PROXIMAL SEAL SYS 4.3MM | ENDOSCOPIC VESSEL HARVESTING | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3043 | 25093113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |