FDA Adverse Event
Other
Summary report: N
BOOMERANG 610
MDR report key: 667660
·
Received January 24, 2006
Report
- Report Number
- 3004182619-2006-00001
- Event Type
- Other
- Date Received
- January 24, 2006
- Date of Event
- December 19, 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
PERIPHERAL ANGIOPLASTY - BOOMERANG DEPLOYED SUCCESSFULLY AND DWELLED FOR 2.5 HOURS. DEVICE REMOVED, SITE FINE PRIOR TO REMOVAL. MANUAL COMPRESSION DIFFICULT DUE TO PATIENT SIZE. HEMATOMA DEVELOPED IMMEDIATELY FOLLOWING MANUAL COMPRESSION. PHYSICIAN APPLIED MANUAL COMPRESSION AGAIN FOR 15 MINUTES. ONCE MANUAL COMPRESSION REMOVED, HEMATOMA GREW LARGER. HELD MANUAL COMPRESSION FOR ANOTHER 15 MINUTES. PATIENT RETURNED TO THE HOSPITAL 1 WEEK POST THE PROCEDURE. A HEMATOMA AND PSEUDOANEURYSM ORIGINATED FROM THE DISTAL LEFT COMMON FEMORAL ARTERY. THROMBIN WAS INJECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOOMERANG 610 | VASCULAR CLOSURE DEVICE | MGB | CARDIVA MEDICAL, INC. | BOOMERANG 610 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |