BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2896721 · Received December 28, 2012

    Report

    Report Number
    3005325609-2012-00039
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE AND DETACHED TIP WERE RETURNED AND ANALYZED. THE TIP LUMEN HAD SEPARATED FROM THE CATHETER AT THE RATCHET STEM AND THE LUMEN SHOWED SIGNS OF STRETCHING. THE TIP ASSEMBLY EXHIBITED NECKING OF THE LUMEN AND LIFTING/DAMAGE TO THE PROXIMAL END OF THE OVERMOLD. THE PROXIMAL END OF THE TIP LUMEN SHOWED EVIDENCE OF TENSION FAILURE THAT OCCURRED WHEN THE LUMEN SEPARATED FROM THE DISTAL END OF THE RATCHET STEM. THE EVENT WAS CAUSED BY THE INABILITY TO PREP AN OCCLUDED VESSEL WITH STRONG RECOIL. THE TIP BECAME TRAPPED BY A NARROWED VESSEL SECTION RESULTING IN HIGH TENSILE FORCES. THE DEVICE HISTORY RECORDS FOR THE CATHETER WERE REVIEWED AND NO ANOMALIES NOTED DURING MFG. A CAPA FOR THE TIP DETACHMENT EVENTS WAS OPENED RESULTING IN A DEVICE MODIFICATION TO DECREASE THE RATE OF THESE TYPES OF EVENTS. FDA 510 (K) CLEARANCE (K122546) FOR THIS MODIFICATION WAS RECEIVED ON (B)(4) 2012.

    Description of Event or Problem · 1

    PREDILATION WAS PERFORMED FROM THE POPLITEAL TO THE PROXIMAL SFA. WHILE STENTING ACROSS A NARROWED SEGMENT IN THE DISTAL SFA, THE CATHETER TIP BECAME STUCK AND UPON RETRACTING THE THUMB SLIDE, THE CATHETER TIP DETACHED. THE REMAINDER OF THE STENT WAS DEPLOYED AND THE CATHETER WAS REMOVED. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO BRING THE TIP OUT WITH A SNARE DEVICE AND THE CATHETER TIP FELL OFF THE GUIDEWIRE AND DRIFTED DOWNSTREAM TO THE MID-POPLITEAL. A BALLOON WAS INSERTED IN AN ATTEMPT TO PULL THE TIP UP TO THE PROXIMAL POPLITEAL; THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO SNARE THE TIP AND IT WAS SUCCESSFULLY REMOVED FROM THE BODY. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-6F 01400061

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention GUIDEWIRE: OUTBACK