BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX OVER-THE-WIRE

    MDR report key: 1901306 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05292
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE PRESENCE DRIED BLOOD AND CONTRAST THROUGHOUT THE DISTAL SHAFT. FURTHER VISUAL AND TACTILE EXAMINATION OF THE PROXIMAL HUB AND SHAFT REVEALED NO DAMAGE OR IRREGULARITIES. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED A LONGITUDINAL TEAR MEASURING 3MM IN LENGTH. A TORN PIECE OF BALLOON MATERIAL WAS STILL ATTACHED AND MEASURED 3MM STARTING APPROXIMATELY 0.5MM DISTALLY FROM PROXIMAL MARKER BAND (DISTAL END) MIGRATING PROXIMALLY. MAGNIFIED EXAMINATION OF THE BALLOON MATERIAL AT THE EDGE OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. EXAMINATION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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 A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND ROTATIONAL ABLATION PROCEDURE, A BALLOON TEAR OCCURRED. THE LESIONS WERE LOCATED IN THE CIRCUMFLEX (LCX) ARTERY AND THE CALCIFIED OBTUSE MARGINAL (OM) CORONARY ARTERIES. THE 2.0MM X 15MM APEX BALLOON CATHETER WAS ADVANCED ACROSS THE LESION OVER A NON BSC FLOPPY GUIDE WIRE TO DILATE THE OM LESION. THE 2.0MM X 15MM APEX BALLOON CATHETER WAS ADVANCED DISTAL THEN THE NON BSC FLOPPY GUIDE WIRE WAS REMOVED AND REPLACED WITH AN UNSPECIFIED ROTAWIRE GUIDE WIRE. UPON ATTEMPTING TO REMOVE THE 2.0MM X 15MM APEX BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED. THE WIRE LUMEN OF THE 2.0MM X 15MM APEX BALLOON CATHETER WAS FLUSHED AND A BALLOON LEAK WAS NOTED. A SECOND 2.5MM X 15MM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED ONCE AND WITHDRAWN THROUGH A DEPLOYED STENT. PRIOR TO REUSING THE 2.5MM X 15MM APEX BALLOON CATHETER, A THIN 2MM TO 3MM PIECE OF TORN BALLOON MATERIAL WAS NOTED AT THE BALLOON-CATHETER JUNCTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 H7493895815250 13755758

    Patients

    Seq Age Sex Outcome Treatment
    1 ACS HITORQUE FLOPPY GUIDE WIRE| 2.0MM X 15MM APEX BALLOON CATHETER| ROTAWIRE GUIDE WIRE