BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST SYSTEM

    MDR report key: 1013121 · Received March 14, 2008

    Report

    Report Number
    3004182619-2008-00009
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    September 11, 2007
    Report Date
    February 26, 2008
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K070485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOOMERANG DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. IT WAS REPORTED THE PROD PERFORMED AS INTENDED PER IFU. THERE WAS NO PROD PROBLEM REPORTED AND THERE WAS NO ASSOCIATION WITH THE INCIDENT TO THE BOOMERANG DEVICE. ADDITIONALLY, REVIEW OF THE DEVICE HISTORY LOT RECORD DID NOT REVEAL ANY ISSUES OR OBSERVATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IT APPEARS THE ELEVATION IN BLOOD PRESSURE MAY HAVE PREVENTED GOOD HEMOSTASIS FROM BEING ACHIEVED AND THE HOLE MADE IN THE ARTERY BY THE SHEATH RE-BLED AND FORMED A PSEUDOANEURYSM.

    Description of Event or Problem · 1

    A DIAGNOSTIC PERIPHERAL PROCEDURE WAS PERFORMED IN 2007 ON A FEMALE PT (PT) WITH PVD. A 5 FR 10 CM SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) AND PLAVIX WAS ADMINISTERED. UPON COMPLETION OF THE PROCEDURE, A BOOMERANG CATALYST WIRE (BCW) WAS INSERTED AND DEPLOYED THROUGH THE INDWELLING SHEATH WITHOUT PROBLEM. TEMPORARY TAMPONADE OF THE ARTERIAL ACCESS SITE WAS SUCCESSFULLY ACHIEVED; EVIDENCED BY NO OOZING NOTED. PT BLOOD PRESSURE STARTED TO ELEVATE AND PHYSICIAN ELECTED TO PULL THE BCW. 20 MG LABATALOL WAS ADMINISTERED. THE BOOMERANG WAS REMOVED WITHOUT PROBLEM; THEN MANUAL COMPRESSION WAS APPLIED TO THE ARTERIOTOMY SITE UNTIL HEMOSTASIS WAS ACHIEVED. FOLLOWING MANUAL COMPRESSION APPLICATION OF A SMALL HEMATOMA STARTED TO FORM. ULTIMATELY, A PSEUDOANEURYSM WAS CONFIRMED AND THROMBIN INJECTION WAS ADMINISTERED UNDER US. PT WAS ADMITTED OVERNIGHT FOR OBSERVATIONS. NO FURTHER INTERVENTION WAS REQUIRED. PT WAS DISCHARGED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST SYSTEM VASCULAR CLAMP MGB CARDIVA MEDICAL, INC. 400-580P 580P070818A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5 FR 10 CM SHEATH