BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCUBA CO-CR STENT

    MDR report key: 3925209 · Received July 10, 2014

    Report

    Report Number
    3004066202-2014-00106
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 10, 2014
    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: INHERENT RISK OF PROCEDURE (STENT EMBOLIZATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (90% STENOSIS). EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE (STENT EMBOLIZATION) 50 DEVICE FAILURE RELATED TO PATIENT CONDITION (90% STENOSIS). CONCLUSION NOT YET AVAILABLE (EVALUATION IN PROGRESS). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED IN THE ORIGINAL BOX WITH ITS PLASTIC POUCH AND TRAY. NO ABNORMALITIES WERE DETECTED ON THE SHAFT. THE STENT WAS DISPLACED FROM THE PROXIMAL MARKER TO THE DISTAL. 2 STRUTS OF THE PROXIMAL END OF THE STENT WERE DAMAGED AND PROFILE OUT OF SPECIFICATION. THE DISTAL PART OF THE STENT WAS OVER THE DISTAL MARKER SO THE PROFILE WAS OUT OF THE SPECIFICATION. BALLOON WAS ANALYZED AND THE HEAT SETTING MARKS WERE CLEARLY RECOGNIZED CLOSE TO THE MARKER BANDS ON THE PROXIMAL SIDE. ON THE SURFACE OF THE BALLOON, CRIMPING MARKS OF THE STENT WERE IDENTIFIED

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO TREAT A LESION WITH A SCUBA CO-CR PERIPHERAL BARE METAL STENT. THE LESION EXHIBITED 90% STENOSIS AND WAS NOT PREDILATED. DURING THE PROCEDURE THE STENT MOVED FROM ITS ORIGINAL POSITION AS THE PHYSICIAN ADVANCED TO THE LESION. THE PHYSICIAN REMOVED THE DEVICE AND CHANGED TO ANOTHER SCUBA, HOWEVER, THE SECOND DEVICE WAS ALSO LOOSE DURING ADVANCEMENT TO THE LESION. THE PHYSICIAN REMOVED THE SCUBA AND GAVE UP THE SURGERY. NO PATIENT COMPLICATIONS. IT WAS CONFIRMED THAT BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO RESISTANCE WITH ACCESSORY EQUIPMENT OR DURING DELIVERY TO THE LESION. NO POSITIVE PRESSURE APPLIED TO THE DEVICE DURING PREPARATION. DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. PLEASE NOTE THAT THIS DEVICE (SCUBA CO-CR) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (SCUBA BILIARY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404987 SCUBA CO-CR STENT CATHETER, BILIARY, DIAGNOSTIC FGE INVATEC SPA 1E022268

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR