BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 3080511 · Received April 26, 2013

    Report

    Report Number
    2134265-2013-02730
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN APEX BALLOON CATHETER WITH BLOOD IN THE HUB AND INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THE SHAFT WAS KINKED 1CM PROXIMAL OF THE EXIT NOTCH AND 2 CM DISTAL OF THE EXIT NOTCH. THE OUTER SHAFT WAS TWISTED WITH A HOLE/PERFORATION THAT LINED UP WITH THE TWIST FROM THE EXIT NOTCH TO 2CM DISTAL OF THE EXIT NOTCH. THE OUTER SHAFT WAS BUNCHED 2.25 - 2.5CM FROM THE DISTAL TIP. THE INNER SHAFT WAS BUNCHED .5 . 2CM AND 4CM FROM THE DISTAL TIP. MAJORITY OF THE BALLOON WAS BUNCHED. THE DISTAL TIP WAS DAMAGED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THERE WAS A HOLE IN THE SHAFT OF THE DEVICE. THE LESION WAS LOCATED IN A BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN CROSSED THE LESION WITH THE APEX MR 2.50MM X 15MM BALLOON. THEY ATTEMPTED TO PULL NEGATIVE PRESSURE PRIOR TO INFLATION AND BLOOD CAME BACK INTO THE INFLATION DEVICE. IT APPEARED THAT THE SHAFT OF THE DEVICE WAS SEVERELY KINKED THAT A HOLE APPEARED. THE PROCEDURE WAS COMPLETED WITH A 2.5X15MM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182982 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895915250 15875608

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR