BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2943627 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00237
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. 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

    SAME CASE AS MFR #: 2134265-2013-00238, 00239, 00240, 00241, 00242, AND 00243. IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INNOMINATE VESSEL. THE 8.0X80, 135CM MUSTANG BALLOON WAS INFLATED AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. (THIS OCCURRED MULTIPLE TIMES DURING THE PROCEDURE WITH DIFFERENT BALLONS.) NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48573 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171080810 15499036

    Patients

    Seq Age Sex Outcome Treatment
    1