BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTA PRO7MM 4CM X 80CM

    MDR report key: 2982229 · Received November 14, 2006

    Report

    Report Number
    9610978-2006-00478
    Event Type
    Malfunction
    Date Received
    November 14, 2006
    Date of Event
    July 18, 2006
    Report Date
    November 14, 2006
    Manufacturer
    CORDIS RODEN
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON BURST DURING HAND INFLATION IN THE FEMORAL ARTERY, WHICH WAS DESCRIBED AS CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OPTA PRO BALLOON. THERE WAS NO REPORT OF PT INJURY. AS PER THE REPORTING AFFILIATE, NO ADD'L PROCEDURAL INFO IS AVAILABLE. THE PRODUCT IS AVAILABLE FOR EVAL AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVE TO DATE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO7MM 4CM X 80CM PTA CATHETERS LIT CORDIS RODEN NA R1005769

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CONCOMITANT DEVICES