BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 120X30

    MDR report key: 1883338 · Received September 21, 2010

    Report

    Report Number
    2953724-2010-00132
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 16, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) FOR PRODUCT (B)(4), LOT P0930150, WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. THE CUSTOMER SAMPLES WERE RECEIVED BY THE PLANT FOR EVAL. UPON RECEIVING THE SAMPLE DEVICE, THE CATHETER WAS FOUND TWISTED WITH THE DISPERSION WIRE INSIDE THE CATHETER. THE CATHETER TWISTED 40.10 INCHES TO 44.10 INCHES FROM THE TIP OF THE PROXIMAL MANIFOLD LUER. THE CATHETER TWISTED IN THE SAME DIRECTION AS THE DISPERSION WIRE ROTATION, COUNTER CLOCKWISE. THE DISPERSION WIRE COMPONENTS WERE STILL ATTACHED TO THE BI-PLEX COIL. THE OUTER DIAMETER OF THE WORKING LENGTH WAS MEASURED TO BE 0.0420 INCHES, WHICH IS WITHIN THE LIMITS SPECIFIED. THE ODU MOTOR STALL TORQUE WAS MEASURED TO BE 1.74 OZ-IN. (66 MA), WHICH IS WITHIN THE REQUIREMENTS. THE DISTAL BALLOON WAS OBSERVED TO BE DAMAGED AND FLIPPED INSIDE-OUT AND PUSHED TOWARDS THE DISTAL AREA. THE INVESTIGATION CONFIRMED, THE COMPLAINT AS REPORTED. THE CATHETER WAS FOUND TWISTED, CAUSING THE DISTAL BALLOON TO BE UNABLE TO DEFLATE. DURING WITHDRAWAL, THE DISTAL BALLOON MIGHT HAVE CAUGHT IN THE INTRODUCER SHEATH, CAUSING THE DISTAL BALLOON TO BE DAMAGED AT THE DISTAL END OF THE PROXIMAL WRAPPING AREA AND FLIPPED INSIDE-OUT. AT THIS TIME, THE ROOT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER STATES THAT THE TRELLIS CATHETER HAD TWISTED ABOUT 5 CM PROXIMAL FROM THE DISTAL BALLOON. CUSTOMER REPORTS THAT THEY WERE UNABLE TO DEFLATE THE DISTAL BALLOON. CUSTOMER STATED THAT HE PULLED BACK THE DISTAL BALLOON THROUGH A STRICTURE AT THE LESSER TROCANTER AND POPPED THE BALLOON THEN EXTRACTED THE ENTIRE CATHETER ASSEMBLY. THE DISTAL BALLOON STAYED INTACT AND DID NOT FRAGMENT WHEN IT WAS POPPED. THIS COMPLAINT REPORT HAD BEEN DETERMINED TO BE A REPORTABLE EVENT BASED ON THE EXAMINATION OF THE SAMPLE RETURNED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT812030 P0930150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK