BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1654852 · Received April 6, 2010

    Report

    Report Number
    3005325609-2010-00004
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 15, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE CATHETER WITH STENT WAS RETURNED FOR ANALYSIS. ANALYSIS CONCLUDED THAT THE THUMB SLIDE PIN HAD SHEARED AT THE BASE OF THE THUMB SLIDE AND AT THE BASE OF THE RATCHET BLOCK ASSEMBLY. DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO ANOMALIES NOTED THAT WOULD HAVE LEAD TO THE MALFUNCTION. THIS IS A KNOWN MALFUNCTION AND A CAPA INVESTIGATION FOR THIS ISSUE HAD REVEALED THAT THE STRENGTH OF THE SLIDER PIN MAY BE AS ROBUST AS REQUIRED FOR RATCHETING THE LONGER 6MM DIAMETER STENTS. THEREFORE, A DEVICE MODIFICATION INCLUDING A STRONGER SLIDER PIN WAS MADE TO CORRECT THIS ISSUE. DISTRIBUTION OF THE MODIFIED DEVICES BEGAN ON (B)(6) 2009 AND THERE HAVE BEEN NO REPORTS OF THUMB SLIDE BREAKS WITH THE MODIFIED DEVICES. THERE WAS NO SERIOUS INJURY RELATED TO THIS EVENT. BECAUSE OF A PREVIOUS THUMB SLIDE BREAK THAT RESULTED IN MEDICAL INTERVENTION TO PRECLUDE A SERIOUS INJURY, THIS EVENT IS BEING REPORTED PER THE MEDICAL DEVICE REPORTING GUIDANCE DOCUMENT. THE WEIGHT OF THE PT WAS NOT OBTAINED AND IS NOT RELEVANT TO THIS EVENT. THIS EVENT OCCURRED IN THE (B)(6). THE DEVICE HOLDS THE CE MARK FOR THE INDICATION OF THE PERIPHERAL VASCULATURE IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE THUMB SLIDE OF THE STENT DELIVERY CATHETER AND IT SUBSEQUENTLY BROKE. THE THUMB SLIDE BROKE AFTER APPROX 1CM OF THE STENT WAS DEPLOYED FROM THE CATHETER. THE CATHETER WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-06-150-120-G2 00313045

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR SHEATH: 7FR TERUMO DESTINATION| GUIDEWIRE: ABBOTT STEELCORE| BALLOON: ABBOTT 6MM FOX PLUS