BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1645792 · Received March 19, 2010

    Report

    Report Number
    3005325609-2010-00002
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 22, 2010
    Report Date
    February 22, 2010
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE CATHETER SYSTEM WAS RETURNED AND ANALYZED. ANALYSIS CONCLUDED THAT THE THUMB SLIDE PIN HAD SHEARED AT THE INTERFACE OF THE RATCHET BLOCK. THE THUMB SLIDE SHEAR WAS CONSISTENT WITH PREVIOUSLY REPORTED EVENTS. A CAPA THAT HAD BEEN OPENED TO FURTHER INVESTIGATE THUMB SLIDE BREAKS RESULTED IN A THUMB SLIDE PIN MATERIAL MODIFICATION. THERE HAVE BEEN NO FURTHER REPORTS OF THUMB SLIDE BREAKS WITH THE MODIFIED THUMB SLIDE PIN. THIS PARTICULAR EVENT CONSISTED OF ONE OF THE DEVICES WITH THE OLDER THUMB SLIDE PINS. THERE HAVE BEEN 10 REPORTED THUMB SLIDE BREAKS OUT OF APPROX 14,375 IMPLANTS WHICH RESULTS IN A 0.07% THUMB SLIDE FAILURE RATE. ATTEMPTS WERE MADE TO GET THE PT INFO (ID, BIRTH DATE, GENDER, WEIGHT) HOWEVER, WE WERE NOT ABLE TO OBTAIN IT.

    Description of Event or Problem · 1

    IN THE PROCESS OF DEPLOYING A STENT INTO THE SFA, THE THUMB SLIDE BECAME DISLODGED. THE STENT WAS APPROXIMATELY 75% DEPLOYED. USING A HEMOSTAT CLAMP, THE PHYSICIAN COMPETED THE DEPLOYMENT WITH NO INCIDENCE. 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. S-06-120-120-G2 00303044

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE - GRAND SLAM| SHEATH - 7 FR COOK VULCAN