BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1211584 · Received October 23, 2008

    Report

    Report Number
    3004182619-2008-00016
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K072297
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATES THE DEVICE DID NOT PROVIDE TEMPORARY HEMOSTASIS AS INTENDED. THERE WAS NO INDICATION OF DEVICE PROBLEM REPORTED. THE USER PHYSICIAN STATED THE RETROPERITONEAL HEMORRHAGE (RPH) MAY HAVE OCCURRED DUE TO USER ERROR OR TECHNIQUE. MANUFACTURER REPRESENTATIVE WILL RETRAIN PHYSICIAN ON USE OF DEVICE AND CONTRAINDICATIONS. THE RECOVERY CARE NURSE STATED THE FEMOSTOP INITIALLY WAS NOT APPLIED CORRECTLY WHICH MAY HAVE ALLOWED BLEEDING AND CAUSED UNDUE BLOOD LOSS. DURING CFA ACCESSING, SHEATH INSERTION ISSUES OR MULTIPLE VESSEL PUNCTURES MAY CONTRIBUTE TO A BLEEDING EPISODE. BLEEDING WITH THE CATALYST WIRE IN PLACE MAY INDICATE ADDITIONAL VESSEL WALL PUNCTURES. SINCE NO DIAGNOSTIC ANGIOGRAM OR ULTRASOUND WAS REPORTED, VESSEL WALL ISSUES OR ARTERIOTOMY LOCATION WERE NOT DETERMINED. IT SHOULD BE NOTED THAT A HIGHER INCIDENCE OF RPH OCCUR WITH "HIGH STICKS" (SUPRA-INGUINAL) AND "BACK WALL" PUNCTURES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE LOT NUMBER WAS NOT AVAILABLE THUS A BATCH RECORD REVIEW COULD NOT BE CONDUCTED. THERE WAS NO INDICATION OF DEVICE PROBLEM REPORTED.

    Description of Event or Problem · 1

    A PATIENT (PT) WAS ADMITTED FOR A PLANNED CORONARY INTERVENTIONAL PROCEDURE IN 2008. PT HAS HISTORY OF CAD AND HYPERTENSION. RIGHT COMMON FEMORAL ARTERY WAS ACCESSED USING A 7 FR SHEATH IN A RETROGRADE METHOD. ANGIOMAX, ASA & PLAVIX WERE ADMINISTERED AS THE ANTICOAGULANTS. UPON COMPLETION OF THE PROCEDURE, A CATALYST II WIRE WAS INSERTED AND DEPLOYED THRU THE INDWELLING SHEATH WITHOUT PROBLEM, HOWEVER, TEMPORARY HEMOSTASIS WAS NOT OBTAINED AS DEMONSTRATED BY INITIAL OOZING FROM THE INSERTION SITE. THE PHYSICIAN ATTEMPTED TO RE-POSITION THE DISC BY ADVANCING FORWARD WHEN FRANK BLEEDING OCCURRED ONCE THE DISC WAS MOVED DISTAL TO THE ARTERIOTOMY. THE PHYSICIAN WAS UNABLE TO RESEAT THE DISC SUCCESSFULLY AND THE DEVICE WAS REMOVED WITHOUT PROBLEM PER THE MANUFACTURER'S INSTRUCTIONS FOR USE. PHYSICIAN WAS NOT SURE IF HE DAMAGED THE VESSEL WITH DISC ADJUSTMENT. MECHANICAL COMPRESSION WAS APPLIED USING FEMOSTOP DEVICE AND PATIENT TRANSPORTED TO RECOVERY. UPON ARRIVAL IN RECOVERY AREA, THE NURSE OBSERVED THAT THE FEMOSTOP DID NOT APPEAR TO BE APPLIED PROPERLY AND REPOSITIONED THE DEVICE. PT SUFFERED A RETROPERITONEAL HEMORRHAGE AND RECEIVED APPROXIMATELY 3 UNITS OF PRBC. PT 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 7 FR SHEATH