BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG

    MDR report key: 854683 · Received May 21, 2007

    Report

    Report Number
    3004182619-2007-00009
    Event Type
    Other
    Date Received
    May 21, 2007
    Date of Event
    May 8, 2007
    Report Date
    May 22, 2007
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    DXC
    PMA / PMN Number
    K070485
    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

    PATIENT ADMITTED TO HOSPITAL C/O ABDOMINAL PAIN; SENT TO CATH LAB FOR CARDIOVASCULAR WORK-UP; FEMORAL ARTERY ACCESS OBTAINED AFTER 6 UNSUCCESSFUL ATTEMPTS TO ACCESS ARTERY; DIFFICULTY DUE TO PRIOR BILATERAL FEM POP BYPASS SURGERY WITH ANASTOMOSES IN AREA AND 80% PVD LESION IN VESSEL. PRIOR TO PROCEDURE PATIENT ON DAILY ORAL DOSES OF ASPIRIN 80MG AND PLAVIX 75MG TO PREVENT CLOTTING; GIVE HEPARIN 5000 UNITS IV BOLUS DURING PROCEDURE. FOLLOWING PROCEDURE BOOMERANG WIRE DEPLOYED BUT UNABLE TO GET TEMPORARY HEMOSTASIS; SYSTOLIC BP >200 MMHG: DEVICE REMOVED AND MANUAL COMPRESSION APPLIED; APPEARED HEMOSTASIS ACHIEVED; BP DROPPED 88/40; PT SENT FOR CT SCAN W/ ABDOMINAL MASS NOTED; SENT TO SURGERY; CLOSED SUPRAINGUINAL ARTERIOTOMY THAT HAD BLED INTO PELVIC VAULT. PER SURGEON, PROBLEM NOT DEVICE RELATED; PROBLEM DUE TO SUPRAINGUINAL ARTERIAL ACCESS THAT COULD NOT BE CLOSED WITH MANUAL COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG VASCULAR CLOSURE DEVICE DXC CARDIVA MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ASA| HEPARIN 5000 U IV BOLUS| PLAVIX PO DAILY