FDA Adverse Event
Other
Summary report: N
BOOMERANG 610
MDR report key: 820127
·
Received February 9, 2007
Report
- Report Number
- 3004182619-2007-00001
- Event Type
- Other
- Date Received
- February 9, 2007
- Date of Event
- January 17, 2007
- 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
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
PT UNDERWENT DIAGNOSTIC PROCEDURE WITH SUCCESSFUL BOOMERANG PLACEMENT. DWELL TIME WAS 30 MINUTES AND MANUAL COMPRESSION TIME WAS 8 MINUTES TO ACHIEVE FINAL HEMOSTASIS. PT SAT UP 2 HOURS POST FINAL HEMOSTASIS AND STARTED BLEEDING. FEMOSTOP WAS APPLIED. THE PT REMOVED THE FEMOSTOP. THE FOLLOWING MORNING A DOPPLER INDICATED A SMALL PSEUDOANEURYSM. SUCCESSFUL COMPRESSION WAS COMPLETED BY THE TECHNICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOOMERANG 610 | BOOMERANG 610 | MGB | CARDIVA MEDICAL, INC. | B610 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |