BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 1011795 · Received March 11, 2008

    Report

    Report Number
    9616099-2008-00594
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 20, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CORONARY INTERVENTION, A FIRESTAR PTCA BALLOON CATHETER INFLATED NORMALLY BUT TOOK APPROX 2 MINUTES TO DEFLATE COMPLETELY. THE PRODUCT WAS REMOVED NORMALLY AND NO PT INJURY OCCURRED. AS REPORTED, THE CONTRAST TO SALINE RATIO USED FOR INFLATION MEDIA WAS 50:50; NO OTHER DETAILS WERE PROVIDED. THE PRODUCT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. WITHOUT RETURN OF THE DEVICE INVOLVED, THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE AVAILABLE INFO DOES NOT MAKE IT POSSIBLE TO DETERMINE WHAT CAUSED THE DEFLATION DIFFICULTY WITH ANY CERTAINTY; HOWEVER, BASED ON REPORTS OF DEFLATION DIFFICULTIES ENCOUNTERED WITH THE FIRE STAR PTCA BALLOON CATHETER, CORDIS CORPORATION HAS INITIATED A WORLDWIDE VOLUNTARY RECALL FOR ALL DISTRIBUTED LOTS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE BALLOON INFLATED NORMALLY; HOWEVER, DURING DEFLATION, THE BALLOON DEFLATED SLOWLY AND IT TOOK APPROX TWO MINUTES FOR THE BALLOON TO FULLY DEFLATE. THE DEVICE WAS USED IN A NORMAL MANNER WITH 50/50 CONTRAST. UPON FULL DEFLATION, THE BALLOON WAS REMOVED NORMALLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INJURY OR ADVERSE EVENT TO THE PATIENT. THERE WAS NO OTHER EVENT, PT OR PROCEDURE INFO AVAILABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK