BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCUBA CO-CR STENT

    MDR report key: 3181213 · Received June 21, 2013

    Report

    Report Number
    3004066202-2013-00094
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    FGE
    PMA / PMN Number
    K092352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). CONCLUSION: UNABLE TO CONFIRM COMPLAINTS. (B)(4).

    Additional Manufacturer Narrative · 1

    RELATED TO OPERATIONAL CONTEXT- THE STENT DISLODGEMENT MOST LIKELY OCCURED DUE TO THE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO IMPLANT A SCUBA STENT TO TREAT AL LESION IN A PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION HAD BEEN PRE-DILATED. THE SCUBA STENT WAS ADVANCED ON THE GUIDE WIRE, THROUGH THE HAEMOSTATIC VALVE AND INTO THE SHEATH WITH NO RESISTANCE NOTED. NEGATIVE OR POSITIVE PRESSURE WAS NOT APPLIED TO THE DEVICE PRIOR TO PLACEMENT OF THE STENT TO THE LESION. HOWEVER, BEFORE THE STENT REACHED THE TARGET LESION, IT WAS NOTED THAT, ALTHOUGH THE STENT WAS NOT DISLODGED IN VIVO, IT HAD MOVED FROM ITS ORIGINAL POSITION ON THE BALLOON OF THE DELIVERY SYSTEM AND IT WAS NOT LONGER POSITIONED ON THE BALLOON. THE DEVICE AND STENT WERE REMOVED FROM THE PATIENT. THE BALLOON HAD NOT BEEN INFLATED WHEN THE ISSUE WAS NOTED. IT WAS REPORTED THAT NO HEALTH HAZARD WAS CAUSED TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE STENT WAS DISPLACED FORM ITS ORIGINAL POSITION ON THE BALLOON FROM THE PROXIMAL MARKER TO THE DISTAL MARKER BAND APPROXIMATELY 2 MM. TRACES OF BLOOD WERE DETECTED. NO OTHER ABNORMALITIES WERE DETECTED ON THE SHAFT. THE DISTAL PART OF THE STENT WAS OVER THE DISTAL MARKER ;THE PROFILE WAS OUT OF THE SPEC (2.19MM) DUE TO THE DISPLACEMENT. THE CROSSING PROFILE WAS MEASURED ON THE PROXIMAL END (2.09MM) AND WAS IN TOLERANCE. BALLOON WAS ANALYZED AND THE HEAT SETTING MARKS WERE CLEARLY RECOGNIZED CLOSE TO THE MARKER BANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283852 SCUBA CO-CR STENT CATHETER, BILIARY, DIAGNOSTIC FGE INVATEC SPA 1D012794

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR