BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX?

    MDR report key: 3201032 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04427
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE APEX CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 5 MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE AND VESSEL DISSECTION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 20MM APEX BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING INFLATION, THE BALLOON WAS UNABLE TO INCREASE PRESSURE TO MORE THAN 6 ATMS. A BALLOON RUPTURE WAS SUSPECTED AND THE DEVICE WAS REMOVED SMOOTHLY FROM THE PATIENT'S BODY. BASED ON THE ANGIOGRAPHY, THE CONTRAST MEDIUM REMAINED AT THE RUPTURE SITE AND DISSECTION WAS NOTED. AN ATTEMPT TO PERFORM AN INTRAVASCULAR ULTRASOUND (IVUS) WAS DONE HOWEVER, THE CATHETER COULD NOT CROSS THE LESION. A 2.5MM NON-BSC BALLOON CATHETER WAS THEN USED TO DILATE THE LESION AND IVUS WAS PERFORMED. VESSEL DISSECTION WAS CONFIRMED. A NON-BSC STENT WAS THEN DEPLOYED AND THE LAD MAIN BRANCH WAS OPENED. FINAL ANGIOGRAPHY WAS PERFORMED AND IT WAS CONFIRMED THAT CONTRAST MEDIUM WAS STILL STAYING IN THE DISTAL PORTION OF LAD. THE PHYSICIAN CONSIDERED THE DISSECTION RESOLVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303152 APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895920250 0013989265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDING CATHETER:LAUNCHER7FR, SL3.5| GUIDEWIRE:BALANCE, FIELDER