BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2572631 · Received May 8, 2012

    Report

    Report Number
    3005325609-2012-00013
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 12, 2012
    Report Date
    April 19, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE CATHETER WAS EXERCISED AND THERE WERE NO NOTED ISSUES. THE TIP OVERMOLD WAS EXAMINED; LIFTING AND SPLITTING OF THE PROXIMAL END OF THE TIP WAS NOTED. THE OVERMOLD WAS ON THE GUIDE WIRE. NECKING OF THE TIP LUMEN AT APPROXIMATELY 15MM FROM THE DISTAL END WAS NOTED. THE THERMAL BOND AT THE RATCHET STEM WAS INTACT. DAMGE TO THE DISTAL END OF THE TERUMO INTRODUCER SHEATH WAS OBSERVED. IT WAS CONCLUDED THAT THE PROXIMAL END OF THE TIP INTERACTED WITH THE DISTAL END OF THE INTRODUCER SHEATH DURING DEVICE WITHDRAWAL AFTER SUCCESSFULLY IMPLANTING THE STENT. THE IPSILATERAL VESSEL APPROACH WITH A SHORT INTRODUCER (10CM) LIKELY CREATED A SHARP DISTAL END ANGLE OF THE INTRODUCER IN THE VESSEL. AS THE PHYSICIAN EXTRACTED THE STENT DELIVERY SYSTEM THROUGH THE INTRODUCER, THE TIP OVERMOLD WAS ANGULATED BY THE INTRODUCER AND THE INTRODUCER'S DISTAL EDGE SNAGGED THE PROXIMAL END OF THE TIP OVERMOLD. THE TIP LUMEN STRETCHED SLIGHTLY WITH THE OVERMOLD BOND TO THE LUMEN RESULTING IN DETACHMENT OF THE OVERMOLD. A CAPA FOR THIS TYPE OF EVENT HAS BEEN OPENED.

    Description of Event or Problem · 1

    TWO STENTS WERE SUCCESSFULLY PLACED IN AN SFA. DURING FLUOROSCOPY POST PROCEDURE, THE CATHETER TIP WAS OBSERVED TO BE IN THE PROXIMAL POPLITEAL SEGMENT. THE TIP STAYED ON THE GUIDEWIRE AND IT WAS REMOVED. THERE WAS NO EFFECT TO THE PT. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-150-80-6F 01129012

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR SHEATH: 6FR TERUMO| GUIDEWIRE: BOSTON SCIENTIFIC 0.014"