BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME EP CATHETER, 6F, QUADRIPOLAR, JSN

    MDR report key: 1033529 · Received April 24, 2008

    Report

    Report Number
    2182269-2008-00118
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F SUPREME EP CATHETER WAS RECEIVED FOR EVAL. VISUAL INSPECTION REVEALED A SMOOTH SEPARATION AT THE BOND WITH MINIMAL TO NO ELONGATION OF THE MATERIAL ON EITHER SIDE OF THE BOND. IT WAS CONFIRMED THAT THE CATHETER WAS RECEIVED WITH A SEPARATION OF THE GRAY SHAFT FROM THE BLACK BODY. ALTHOUGH, WE WERE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE FOR THE SEPARATION, TESTING HAS SHOWN THIS ISSUE MAY BE THE RESULT OF OVER-TORQUING THE CATHETER OR DEFLECTING THE CATHETER WHILE THE TIP REMAINS IN THE INTRODUCER SHAFT. ALTHOUGH THE LOT NUMBER IS UNKNOWN IN THIS CASE, OUR RECORDS SHOW THAT THERE ARE NO SIGNIFICANT ABNORMAL TRENDS OF SIMILAR COMPLAINTS ACROSS THE PRODUCT LOTS DISTRIBUTED WORLDWIDE. NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS REORDER NUMBER AND FRENCH SIZE. CONSISTENT WITH ST. JUDE MEDICAL'S COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT, WE WILL CONTINUE TO MONITOR THE ONGOING PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER SEPARATED BETWEEN THE GRAY AND BLACK PORTION OF THE SHAFT. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER, 6F, QUADRIPOLAR, JSN SUPREME EP, 6F, JSN DRF ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention