BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1151366 · Received September 3, 2008

    Report

    Report Number
    3004182619-2008-00015
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K072297
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. THE BATCH RECORD WAS REVIEWED AND THERE WERE NO OBSERVATIONS NOTED ON THE BATCH RECORD THAT COULD CONTRIBUTE TO THE REPORTED INCIDENT. ALL DEVICES ARE 100% QC FINAL INSPECTED AND TESTED FOR FUNCTIONALITY. DEVICE OPERATED AS INTENDED AND FINAL HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. RISK FACTORS FOR PSEUDOANEURYSM INCLUDE ADVANCED AGE, LARGE BORE CATHETER, GENDER, ANTICOAGULANT USE AND POOR TECHNIQUE. NO FURTHER INFO REGARDING THE EVENT COULD BE OBTAINED FROM THE HOSPITAL OR PHYSICIAN.

    Description of Event or Problem · 1

    THE MALE WAS ADMITTED FOR AN INTERVENTIONAL PROCEDURE IN 2008 ~ PATIENT HAS HISTORY OF MULTIPLE COMORBIDITIES INCLUDING HYPERTENSION, PVD AND COPD. LEFT COMMON FEMORAL ARTERY (LCFA) WAS ACCESSED VIA A RETROGRADE PUNCTURE. A 6 FR SHEATH WAS USED IN LCFA TO GAIN ACCESS. HEPARIN WAS ADMINISTERED AS THE ANTICOAGULANT. UPON COMPLETION OF PROCEDURE, A BOOMERANG CATALYST II WIRE (BCW) WAS INSERTED AND DEPLOYED THRU THE INDWELLING SHEATH WITHOUT WITHOUT PROBLEM; SHEATH REMOVED. TEMPORARY TAMPONADE OF THE ARTERIOTOMY WAS SUCCESSFULLY ACHIEVED AS EVIDENCED BY NO BLEEDING OR HEMATOMA FORMATION BEING NOTED DURING DEVICE DWELL (5 MIN). BCW PERFORMED AS INDICATED AND WAS REMOVED WITHOUT PROBLEM; MANUAL COMPRESSION WAS APPLIED FOR 10 MIN TO PROVIDE FINAL HEMOSTASIS. TWO DAYS POST OP, PT WAS PRESENTED WITH A GROWING HEMATOMA AND PAIN. US WAS PERFORMED AND REVEALED A PSEUDOANEURYSM. PSEUDOANEURYSM WAS TREATED WITH COILS. PATIENT RECOVERED WITHOUT SEQUELAE AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST II SYSTEM VASCULAR CLAMP MGB CARDIVA MEDICAL, INC. 500-580C 580C080529A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 6 FR SHEATH.