FDA Adverse Event
Malfunction
Summary report: N
10 MM HEMASHIELD ARTERIAL CANNULA
MDR report key: 1013995
·
Received March 13, 2008
Report
- Report Number
- 1220648-2008-00002
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- February 2, 2008
- Report Date
- March 11, 2008
- Manufacturer
- ABIOMED, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P900023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PATIENT EXPIRED IN 2008 DUE TO MULTI-SYMPTOM ORGAN FAILURE (MSOF), WHICH WAS UNRELATED TO BLEEDING THROUGH HEMASHIELD. GRAFT WAS NOT RETRIEVED. UAB HAS NOT COOPERATED WITH ABIOMED IN PROVIDING CANNULA LOT NUMBERS. ABIOMED WILL CONTINUE TO REQUEST THIS INFORMATION. RESULTS AND CONCLUSIONS WILL BE SUMMARIZED IN FOLLOW-UP / FINAL REPORT.
Description of Event or Problem · 1
SURGEON REPORTED EXCESSIVE BLEEDING THROUGH HEMASHIELD ARTERIAL GRAFT AND HAD TO COVER GRAFT WITH A SECOND BOSTON SCIENTIFIC GRAFT TO STOP THE BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 10 MM HEMASHIELD ARTERIAL CANNULA | CARDIAC ASSIST | DSQ | ABIOMED, INC. | TBD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |