FDA Adverse Event
Other
Summary report: N
BOOMERANG 610
MDR report key: 658076
·
Received December 29, 2005
Report
- Report Number
- 3004182619-2005-00004
- Event Type
- Other
- Date Received
- December 29, 2005
- Date of Event
- December 8, 2005
- Report Date
- December 29, 2005
- Manufacturer
- CARDIVA MEDICAL, INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT'S BLOOD PRESSURE DROPPED APPROXIMATELY 1 HOUR POST REMOVAL OF THE BOOMERANG. A CT SCAN WAS PERFORMED AND A RETROPERITONEAL HEMATOMA WAS NOTICED. PATIENT IS OBESE, THE STICK WAS HIGH (NO GROIN SHOT WAS TAKEN), AND THERE WAS A POSSIBILITY THAT THE PHYSICIAN STUCK THE PATIENT TWICE. THE BOOMERANG 610 DWELLED FOR 15 MINUTES WITH 5 MINUTES OF MANUAL COMPRESSION. THERE WAS NO OOZING. BLOOD WAS GIVEN TO THE PATIENT WHO IS NOW STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOOMERANG 610 | VASCULAR CLOSURE DEVICE | MGB | CARDIVA MEDICAL, INC. | BOOMERANG 610 | 610051123A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |