BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLEX TESIO CATH

    MDR report key: 3223814 · Received July 10, 2013

    Report

    Report Number
    2518902-2013-00034
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    PMA / PMN Number
    12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SEGMENT OF ONE VENOUS TESIO LUMEN WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE CATHETER REVEALED THAT THE LUMEN IS FRACTURED AT THE EDGE OF THE CUFF RETAINER PROXIMAL TO THE TIP. THE EDGE OF THE BREAK IS JAGGED. PICTURES WERE PROVIDED OF THE INTERNAL PORTION OF THE LUMEN THAT WAS NOT RETURNED. THERE IS A 7.7 CM SEGMENT OF LUMEN PRESENT FROM THE OPPOSITE END OF THE CUFF RETAINER-THE-EXTERNAL PORTION OF THE DEVICE. THERE IS NO EVIDENCE OF SWELLING, CRUMBLING, DISCOLORATION, DEGRADATION OR POLYMER VARIATION OF THE LUMEN MATERIAL. THE LUMEN WAS MEASURED. ALL MEASUREMENTS WERE WITHIN THE DIMENSIONAL SPECIFICATIONS. THE INCIDENT REPORT NOTED THAT THE CATHETER WAS IMPLANTED FOR SIX YEARS. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT. THE LONGER A CATHETER IS IMPLANTED AND FUNCTIONING PROPERLY THE LESS LIKELY A CATHETER'S FAILURE CAN BE CONTRIBUTED TO A MANUFACTURING DEFECT OR A FAILURE OF THE PRODUCT'S DESIGN.

    Description of Event or Problem · 1

    THE PATIENT HAVING TESIO CATHETER INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN HAD A BAD BLOOD FLOW DURING DIALYSIS. CONFIRMING WITH X-RAY, THEY FOUND OUT THE CUFF CENTRAL SIDE OF THE V-SIDE CATHETER RUPTURED AND HAD BEEN SPRAYING TO THE RIGHT ATRIUM. THE CATHETER WAS HELD BY SNARE APPROACHED FROM THE RIGHT FEMORAL VEIN AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316033 BIOFLEX TESIO CATH HEMODIALYSIS CATHETER MSD MEDCOMP BFS-6-J UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention