BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY STEERABLE CATHETER 6F, 1110-6-5-L

    MDR report key: 1915560 · Received November 5, 2010

    Report

    Report Number
    2030404-2010-00217
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K060757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED CATHETER CONFIRMED THE DEVICE WAS SEPARATED INTO 2 PIECES 10.5 CM FROM THE DISTAL TIP. ALL INTERNAL COMPONENTS WERE PRESENT. TESTING OF MECHANICAL AND ELECTRICAL FUNCTION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE CATHETER. THE CAUSE FOR THE SEPARATION OF THE CATHETER WAS THE FORCE APPLIED TO REMOVE THE CATHETER FROM THE SHEATH WITH THE REPORTED KNOT. THE CAUSE FOR THE REPORTED KNOT COULD NOT BE DETERMINED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(6) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(6) 2010. THE FOLLOWING DATES ARE ESTIMATED. ONLY THE MONTH/YEAR IS KNOWN EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE CATHETER INTO THE CORONARY SINUS, THE CATHETER BECAME TWISTED IN A LOOP. BY PULLING BACK THE CATHETER IN ORDER TO RESOLVE THIS LOOP, THE CATHETER BECAME KNOTTED. THE PHYSICIAN PULLED THE CATHETER BACK INTO THE VENA CAVA, DOWN THE FEMORAL VEIN AND THEN INTO THE SHEATH. THE CATHETER COULD NOT PASS FREELY THROUGH THE SHEATH, SO THE PHYSICIAN PULLED WITH FORCE WHICH CAUSED THE CATHETER TO SEPARATE INTO 2 PIECES, ONE OF WHICH WAS REMOVED FROM THE PT, THE OTHER OF WHICH REMAINED IN THE SHEATH. THE SHEATH ALONG WITH THE REMAINING PART OF THE CATHETER WERE REMOVED FROM THE PT WITHOUT FURTHER INTERVENTION. A NEW SHEATH WAS PLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY STEERABLE CATHETER 6F, 1110-6-5-L NONE DRF ST JUDE MEDICAL, IRVINE 81107 K31202

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR