FDA Adverse Event
Malfunction
Summary report: N
HEMASHIELD WDV PLATINUM GRAFT
MDR report key: 2241158
·
Received August 17, 2011
Report
- Report Number
- 2242352-2011-01196
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 5, 2011
- Report Date
- August 5, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- DSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FDA METHOD: THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THAT DURING PREPARATION FOR AN OPERATION, A TEAR WAS FOUND ON THE GRAFT. ACCORDING TO THE IMAGE PROVIDED, THE TEAR IS IDENTIFIED AS BEING ON THE AORTA OF THE GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMASHIELD WDV PLATINUM GRAFT | VASCULAR GRAFT | DSY | MAQUET CARDIOVASCULAR, LLC. | 175922P | 12653370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |