BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIIA PTA BALLOON CATHETER

    MDR report key: 844913 · Received February 23, 2007

    Report

    Report Number
    9610978-2007-00107
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 8, 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

    THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES (US); HOWEVER, IT IS SIMILAR TO THE US PRODUCT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS (R1205398) MET ALL REQUIREMENTS PER THE APPLICABLE MQP. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7140192 WITH LOT NUMBER 0411051061 AND 0412050111. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. IN THIS CASE, LESION/VESSEL CHARACTERISTICS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BURST. THE INTENDED PROCEDURE, WAS ANGIOPLASTY OF THE CAROTID ARTERY. THE VESSEL HAD MILD CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED WITH AN INDEFLATOR, HOWEVER, THE BALLOON RUPTURED AT 5ATM. IT IS UNKNOWN IF DIFFICULTY WERE EXPERIENCED WHILE ADVANCING THE CATHETER TO THE LESION OR WHILE CROSSING THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIIA PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R1205398

    Patients

    Seq Age Sex Outcome Treatment
    1 *