BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM THRILL PTA BALLOON CATHETER

    MDR report key: 835760 · Received March 26, 2007

    Report

    Report Number
    9610978-2007-00182
    Event Type
    Malfunction
    Date Received
    March 26, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 13, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MQP. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY WITH LOT NUMBER. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. WITHOUT PRODUCT RETURN, IT CANNOT BE DETERMINED IF THERE WERE ABRASIONS ON THE SURFACE OF THE BALLOON THAT COULD HAVE CAUSED THE BALLOON TO RUPTURE. IN THIS CASE, VESSEL/LESION CHARACTERISTICS LIKELY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE BALLOON RUPTURED DURING PROCEDURE. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF A SHUNT ANASTOMOSIS. THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED, SEVERELY TORTUOUS AND HAD AN 80% STENOSIS. THE BALLOON WAS POSITIONED WITHIN THE TARGET LESION AND INFLATED WITH AN INDEFLATOR; HOWEVER, IT RUPTURED AT 6 ATMOSPHERES. IT IS UNKNOWN IF DIFFICULTY WAS EXPERIENCED DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION OR WHILE CROSSING THE LESION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES (US); HOWEVER, IT IS SIMILAR TO THE US PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM THRILL PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R1106549

    Patients

    Seq Age Sex Outcome Treatment
    1 YR