FDA Adverse Event
Malfunction
Summary report: N
10 MM HEMASHIELD ARTERIAL CANNULA
MDR report key: 960364
·
Received December 5, 2007
Report
- Report Number
- 1220648-2007-00009
- Event Type
- Malfunction
- Date Received
- December 5, 2007
- Date of Event
- October 31, 2007
- Report Date
- December 2, 2007
- Manufacturer
- ABIOMED, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P900023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RETURNED SAMPLES WERE RECEIVED ON 11/28/07. EVALUATION IS IN PROCESS AND EVALUATION SUMMARY, METHOD, RESULTS AND CONCLUSIONS WILL BE SUBMITTED IN SUPPLEMENTAL REPORT. INFORMATION ON SECOND (RIGHT) CANNULA: LOT NUMBER: 1002190. CATALOG NUMBER: 0506-0110-HAR. DEVICE MANUFACTURE DATE: 10/2006. EXPIRATION DATE: 10/31/2008.
Description of Event or Problem · 1
PLASMA LEAKAGE WAS OBSERVED OVER BOTH HEMASHIELD GRAFTS AFTER COMPLETING BI-VAD IMPLANT PROCEDURE. REVERSING HEPARIN WITH PROTAMIN STOPPED THE LEAKAGE ON THE OUTFLOW CANNULA TO THE ASCENDING AORTA, BUT NOT THE PLASMA LEAKAGE OF THE HEMASHIELD GRAFT CONNECTED TO THE PA (PULMONARY ARTERY). THE NEXT DAY, THE SURGEON HAD TO OPEN THE CHEST AGAIN TO COVER THE HEMASHIELD WITH AN ADDITIONAL GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 10 MM HEMASHIELD ARTERIAL CANNULA | CARDIAC ASSIST | DSQ | ABIOMED, INC. | 1011332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |