BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 3052317 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02231
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED DEVICE WAS CONSISTED OF A MUSTANG BALLOON DILATATION CATHETER WITH NO OTHER DEVICES. A VISUAL EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR STRETCHED FROM THE DISTAL EDGE OF PROXIMAL MARKERBAND TO 3MM DISTALLY ALONG THE BALLOON. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. 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 ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED ATRIOVENTRICULAR SHUNT IN THE PATIENT'S FOREARM. A 7.0 X 40, 75CM MUSTANG BALLOON DILATATION CATHETER WAS USED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 9 ATMOSPHERES. THE BALLOON WAS COMPLETELY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED ATRIOVENTRICULAR SHUNT IN THE PATIENT'S FOREARM. A 7.0 X 40, 75CM MUSTANG BALLOON DILATATION CATHETER WAS USED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 9 ATMOSPHERES. THE BALLOON WAS COMPLETELY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155966 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070470 15487228

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH¿TERUMO 5FR| INFLATION DEVICE -KANEKA