BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 990759 · Received January 31, 2008

    Report

    Report Number
    9616099-2008-00251
    Event Type
    Malfunction
    Date Received
    January 31, 2008
    Date of Event
    January 14, 2007
    Report Date
    January 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Removal / Correction Number
    Z-0747-0826-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. PLEASE NOTE THAT BASED ON THE REPORTS OF DEFLATION, DIFFICULTIES ENCOUNTERED WITH THE FIRE STAR PTCA BALLOON CATHETER, CORDIS CORPORATION HAS INITIATED A WORLDWIDE VOLUNTARY RECALL FOR ALL DISTRIBUTED LOTS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING THE PROCEDURE, THE BALLOON WAS VERY SLOW TO DEFLATE; HOWEVER, THE BALLOON DID DEFLATE AND THE SURGEON COMPLETED THE CASE WITH NO FURTHER INTERVENTION. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 13295103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK