BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 120X15

    MDR report key: 4392514 · Received January 7, 2015

    Report

    Report Number
    2183870-2015-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    November 13, 2014
    Report Date
    December 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Removal / Correction Number
    Z-1018-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED TRELLIS CONFIRMED THAT THE BALLOON PORTS WERE INCORRECTLY LABELED: THE PORT THAT INFLATES THE PROXIMAL BALLOON WAS LABELED DIST BALLOON AND THE PORT THAT INFLATES THE DISTAL BALLOON WAS LABELED PROX BALLOON.THIS EVENT HAS BEEN RECLASSIFIED IN SECTION H1 TO A MALFUNCTION DUE TO THE ISSUE WITH THE INFLATION PORT.(B)(4)

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE WAS CONDUCTED.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON AN ILIOFEMORAL DVT VIA THE COMMON FEMORAL VEIN. THE REPORTED EVENT OCCURRED DURING THE PROCEDURE. THE PHYSICIAN POSITIONED THE CATHETER IN THE PATIENT AND TRIED TO INFLATE THE BALLOONS. THE PHYSICIAN NOTICED THE PROXIMAL BALLOON PORT WAS LABELED DISTAL BALLOON YET IT INFLATED THE PROXIMAL BALLOON. THE DISTAL BALLOON PORT WAS LABELED PROXIMAL BALLOON AND WOULD NOT INFLATE. A 10F SHEATH WAS USED IN THIS PROCEDURE. THE PHYSICIAN REMOVED THE TRELLIS FROM THE PATIENT. ONCE REMOVED THE PHYSICIAN ATTEMPTED TO INFLATE THE DISTAL BALLOON THROUGH DISTAL BUT THE CONTRAST/SALINE SOLUTION APPEARED TO BE LEAKING FROM BETWEEN THE CATHETER AND DISTAL BALLOON EDGE. NO INJURY TO THE PATIENT. SECTION J: NO SURGICAL/MEDICAL INTERVENTION REQUIRED. THE PHYSICIAN ASPIRATED THE REMAINDER OF THROMBUS AND PLACED VENOUS STENTS IN COMMON ILIAC VEIN TO COMPLETE PROCEDURE. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2014 FOUND THE DISTAL BALLOON EXHIBITED A FOOTBALL SHAPED HOLE ON THE PROXIMAL END OF THE BALLOON CHAMBER. ADDITIONALLY, THE WHEN THE PORT LABELED DISTAL WAS INFLATED WITH WATER THE PROXIMAL BALLOON WAS INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13495 TRELLIS 8 120X15 CONTINUOUS FLUSH CATHETER KRA COVIDIEN EVT812015V01 9966680

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR