BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG PTA BALLOON DILATATION CATHETER

    MDR report key: 2935655 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00846
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DETACHMENT OCCURRED. THE NON-TORTUOUS AND NON-CALCIFIED TARGET LESION WAS LOCATED IN A RIGHT ARM FISTULA. THE MUSTANG BALLOON WAS INFLATED TO 30ATM AND THE BALLOON RUPTURED INSIDE THE FISTULA. A SECTION OF THE BALLOON DETACHED AND WAS REMOVED WITH A DIFFERENT DEVICE. NO ADDITIONAL INTERVENTION WAS PERFORMED ON THE TARGET LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41057 MUSTANG PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK696

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention