BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2920322 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00066
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED WITH A 0.035INCH GUIDEWIRE TRAPPED INSIDE THE DEVICE. THE GUIDEWIRE WAS SEVERELY STRETCHED AT THE SECTION EXITING THE WIRE LUMEN AT THE HUB OF THE DEVICE. AN ATTEMPT TO REMOVE THE WIRE FROM THE DEVICE WAS MET WITH RESISTANCE. AS A RESULT THE SHAFT WAS DISSECTED AT VARIOUS LOCATIONS AND EVENTUALLY THE GUIDEWIRE WAS REMOVED. NO ANOMALIES WERE NOTED. THE BALLOON IS PARTIALLY INFLATED WITH CONTRAST MEDIA. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE BALLOON STUCK ON THE WIRE. THE DETAILS OF THE LESION ARE UNKNOWN. THE 7.0 X 80, 75CM MUSTANG BALLOON CATHETER BECAME STUCK ON A NON-BSC GUIDEWIRE. DETAILS OF HOW THE PROCEDURE WAS COMPLETED IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE BALLOON STUCK ON THE WIRE. THE DETAILS OF THE LESION ARE UNKNOWN. THE 7.0 X 80, 75CM MUSTANG BALLOON CATHETER BECAME STUCK ON A NON-BSC GUIDEWIRE. DETAILS OF HOW THE PROCEDURE WAS COMPLETED IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26033 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070870 15683997

    Patients

    Seq Age Sex Outcome Treatment
    1