FDA Adverse Event
Other
Summary report: N
BOOMERANG 610
MDR report key: 799395
·
Received December 16, 2006
Report
- Report Number
- 3004182619-2006-00016
- Event Type
- Other
- Date Received
- December 16, 2006
- Date of Event
- November 20, 2006
- Report Date
- December 15, 2006
- 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
PHYSICIAN INDICATED THE INJURY WAS SMALL AND WOULD HEAL ITSELF.
Description of Event or Problem · 1
PHYSICIAN ADVANCED BOOMERANG AND FELT RESISTANCE, PULLED BACK. HE ADVANCED AGAIN, FELT RESISTANCE. THE ANGIO PICTURE SHOWED THE BOOMERANG SUB-INTIMAL, SMALL DISSECTION. PATIENT ON HEPARIN AND GP IIB/IIIA.
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 | Other |