BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCUBA CO-CR STENT

    MDR report key: 2880986 · Received December 20, 2012

    Report

    Report Number
    3004066202-2012-00158
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    January 16, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    FGE
    PMA / PMN Number
    K092352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED IN SUBCLAVIAN ARTERY. CONCLUSION: USED IN SUBCLAVIAN ARTERY.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: FAILURE TO FOLLOW INSTRUCTIONS ( USED IN SUBCLAVIAN ARTERY); INCORRECT TECHNIQUE/PROCEDURE (PRESSURE APPLIED TO DEVICE PRIOR TO PLACEMENT AT LESION). CONCLUSION: DEVICE FAILURE RELATED TO USE HANDLING( PRESSURE APPLIED TO DEVICE); FAILURE TO FOLLOW INSTRUCTIONS (IFU NOT ADHERED TO).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A STENOSIS IN THE LEFT SUBCLAVIAN ARTERY. AT THE TIME OF INSERTING THE SCUBA DEVICE THROUGH THE SHEATH MILD RESISTANCE/ FRICTION WAS ENCOUNTERED. WHEN THE STENT WAS PLACED AT THE LESION THE PHYSICIAN NOTED THAT THE STENT DID NOT CONFORM WITH THE MARKER ON THE BALLOON. THE DEVICE WAS REMOVED AND A SECOND SCUBA DEVICE WAS INSERTED HOWEVER IT WAS REPORTED THAT THE SAME RESISTANCE OCCURRED. AFTER THE SECOND DEVICE WAS REMOVED, A NEW SHEATH WAS USED HOWEVER WHEN A THIRD SCUBA WAS ADVANCED IT WAS NOTED THAT THE STENT DID NOT LINE UP WITH THE MARKER ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH AND A FOURTH SCUBA DEVICE. NO STENT DISLODGED IN THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION. NO OTHER ABNORMALITIES WERE DETECTED ON THE SHAFT. THE STENT WAS POSITIONED ON THE BALLOON BUT HAD MOVED DISTALLY AND WAS PLACED OVER THE DISTAL MARKER SO THE STENT OD PROFILE WAS OUT OF THE SPECIFICATION. HEAT MARK AND CRIMP SETTINGS WERE EVIDENT ON THE BALLOON SURFACE. CINE IMAGE REVIEW A CD WITH THE ANGIO IMAGES OF THE PROCEDURE WERE RECEIVED, BUT NO IMAGES WERE SAVED REGARDING THE ADVANCEMENT OF RETRACTION OF THE THREE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCUBA CO-CR STENT CATHETER, BILIARY, DIAGNOSTIC FGE INVATEC SPA 1D019815

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR