BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 1030277 · Received April 17, 2008

    Report

    Report Number
    2134265-2008-01123
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. THE XXL BALLOON WAS INFLATED TWICE TO 12 ATMS EACH. WHILE ATTEMPTING TO INFLATE THE BALLOON, THE DISTAL PORTION OF THE SHAFT ON THE SECTION OF THE BALLOON BROKE OFF. THE BROKEN SECTION WAS SUCCESSFULLY REMOVED WITH A SNARE. IT WAS ADDITIONALLY REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE THE BALLOON THROUGH THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other