BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCUBA CO-CR STENT

    MDR report key: 4335653 · Received December 17, 2014

    Report

    Report Number
    3004066202-2014-00206
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    October 21, 2014
    Report Date
    December 22, 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, CONCLUSION: LIMITED INFORMATION- ROOT CAUSE IS UNDETERMINED. CONCLUSION NOT YET AVAILABLE: EVALUATION IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE TO FOLLOW INSTRUCTIONS (USE OF A GUIDE CATHETER AND NOT AN INTRODUCER SHEATH AS RECOMMENDED).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A SCUBA CO-CR STENT PERIPHERAL BARE METAL STENT. NO ABNORMALITY NOTED DURING PREPARATION AND INSPECTION OF THE SCUBA DEVICE PRIOR TO USE. NO ABNORMALITY NOTED WITH THE GUIDE CATHETER PRIOR TO USE. NO NEGATIVE NOR POSITIVE PRESSURE TO THE CATHETER PRIOR TO ATTEMPTED DELIVERY OF THE STENT. NO RESISTANCE NOTED DURING ATTEMPTED DELIVERY. DURING THE SURGERY, THE PHYSICIAN FOUND THE STENT WAS DISLODGED WHEN CROSSING GUIDING BY DIGITAL SUBTRACTION ANGIOGRAPHY. THE PHYSICIAN USED OTHER BRAND OF PRODUCT TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS REPORTED

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE STENT WAS FOUND MOUNTED ON THE BALLOON EXACTLY IN THE MIDDLE OF THE MARKERS. USING THE MICROSCOPE A CORRUGATION WAS FOUND CLOSE TO THE PROXIMAL SIDE OF THE STENT, THAT COULD BE ADDRESSED TO A STENT DISLODGMENT FROM DISTAL SIDE TO THE PROXIMAL ONE, HOWEVER THE POSSIBILITY EXIST THAT PHYSICIAN REPOSITIONED THE STENT AFTER USE. THE STENT OD MEASURED ON THE STENT WAS CONFORMAL TO THE SPECIFICATION .THE STENT WAS MOVED FROM ITS POSITION AND THE HEAT SETTING MARK WERE CLEARLY DETECTED ON BOTH ENDS. A TRIAL TO INSERT THE DEVICE INTO A MEDTRONIC 6F IS WAS PERFORMED AND THE DEVICE PASSED THROUGH THE IS WITHOUT ANY PROBLEM OR DISLODGMENT OCCURRED. 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
    827193 SCUBA CO-CR STENT CATHETER, BILIARY, DIAGNOSTIC FGE INVATEC SPA 1E022274

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR