BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG 56

    MDR report key: 651283 · Received December 9, 2005

    Report

    Report Number
    3004182619-2005-00003
    Event Type
    Other
    Date Received
    December 9, 2005
    Date of Event
    November 18, 2005
    Report Date
    December 7, 2005
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FEMALE PT UNDERWENT DIAGNOSTIC ANGIOGRAPHY TO ASSESS STATUS OF CAD. THE LEFT CIRCUMFLEX BRANCH WAS 100% OCCLUDED WITH GOOD COLLATERALS. FOLLOWING THE PROCEDURE, THE PT HAD THE BOOMERANG 56 CLOSUREWIRE PLACED THROUGH A 6F INTRODUCER SHEATH IN THE RIGHT FEMORAL ARTERY WITHOUT PROBLEM. THE DEVICE DWELLED AND REMOVED WITHOUT PROBLEM OR EVIDENCE OF BLEEDING IN TISSUE TRACT. FOLLOWING MANUAL COMPRESSION, WHILE THE RIGHT PUNCTURE SITE WAS BEING DRESSED, THE PT HAD A VASOVAGAL RESPONSE. ATROPINE AND FLUIDS WERE GIVEN; PT RESPONDED; COMPLAINING OF ABDOMINAL PAIN; FOLEY CATHETER PLACED, BLADDER EMPTIED AND PAIN RELIEVED. SUBSEQUENT LAB SAMPLE DRAWN FROM OPEN IV LINE SHOWED HCT OF 8.9 (ADMITTING HCT 13.1); PT SENT FOR DOPPLER OF RIGHT LOWER EXTREMITY - SHOWED VESSEL PATENT AND W/O PROBLEM; CT SCAN OF RIGHT GROIN SHOWED EVIDENCE OF 4X8CM RETROPERITONEAL HEMATOMA. PT REMAINED IN HOSP FOR OBSERVATION; SUBSEQUENT HCT LEVELS OF 11.7; 10.0; & 10.6. NO BLOOD PRODUCTS WERE GIVEN. ASPIRIN DOSE HELD FOR NOW. PT DISCHARGED WITH SLIGHT TENDERNESS IN RIGHT GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG 56 VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. BOOMERANG 56 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization