BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX OVER-THE-WIRE

    MDR report key: 2021929 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00775
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT BLOOD AND CONTRAST WERE PRESENT THROUGHOUT THE DISTAL LUMEN AND BALLOON. THE DEVICE WAS SOAKED FOR APPROXIMATELY 8 HOURS IN A BATH OF CIRCULATING 37°C WATER TO LOOSEN AND DISLODGE DRIED MATERIAL FROM THE LUMEN OF THE DEVICE. AN INFLATION DEVICE WAS USED TO PRESSURIZE THE BALLOON AND A PINHOLE WAS FOUND ON THE BALLOON WALL, 9MM FROM DISTAL TIP. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS 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 PROCEDURAL FACTORS. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) SDS WAS ADVANCED BUT DID NOT CROSS THE LESION. THE DEVICE WAS EXCHANGED FOR A 12X2.5MM APEX BALLOON CATHETER. THE BALLOON CATHETER CROSSED THE LESION AND WAS INFLATED TWO TIMES TO 14ATMS HOWEVER A BALLOON RUPTURE OCCURRED. THE APEX DEVICE WAS REMOVED INTACT FROM THE PATIENT AND IT WAS NOTED THAT FLUID WAS LEAKING FROM THE BALLOON LUMEN. THE STENOSIS WAS REDUCED IN THE LESION SO THE TAXUS LIBERTE SDS WAS READVANCED BUT IT STILL WOULD NOT CROSS. ALL INTERVENTIONAL DEVICES WERE REMOVED AND THE PATIENT WAS TREATED MEDICALLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) SDS WAS ADVANCED BUT DID NOT CROSS THE LESION. THE DEVICE WAS EXCHANGED FOR A 12X2.5MM APEX BALLOON CATHETER. THE BALLOON CATHETER CROSSED THE LESION AND WAS INFLATED TWO TIMES TO 14ATMS HOWEVER A BALLOON RUPTURE OCCURRED. THE APEX DEVICE WAS REMOVED INTACT FROM THE PATIENT AND IT WAS NOTED THAT FLUID WAS LEAKING FROM THE BALLOON LUMEN. THE STENOSIS WAS REDUCED IN THE LESION SO THE TAXUS LIBERTE SDS WAS READVANCED BUT IT STILL WOULD NOT CROSS. ALL INTERVENTIONAL DEVICES WERE REMOVED AND THE PATIENT WAS TREATED MEDICALLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895812250 13741353

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR