BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG PTA BALLOON DILATATION CATHETER

    MDR report key: 2213102 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03254
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. EVENT DATE: WEEK OF (B)(6) 2011 DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CAN NOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 75% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CEPHALIC ARCH AND VENOUS ANASTAMOSIS. THE PHYSICIAN ADVANCED THE 10MM MUSTANG BALLOON TO THE LESION AND ON THE THIRD INFLATION, INFLATED THE BALLOON TO UNSPECIFIED ATMS AND THE BALLOON RUPTURED INTO MULTIPLE PIECES. A LARGE PORTION OF THE BALLOON CURLED UP ON ITSELF AND COULDN'T COME THROUGH THE SHEATH. THE PHYSICIAN EXCHANGED THE 7FR SHEATH TO A 9FR SHEATH AND WAS ABLE TO SNARE THE FRAGMENTS EXCEPT FOR ONE. THE PHYSICIAN THEN STENTED THE BALLOON FRAGMENT AGAINST THE VESSEL WALL WITH AN UNSPECIFIED FLARE STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention