BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME?

    MDR report key: 3849854 · Received June 4, 2014

    Report

    Report Number
    3005099803-2014-02115
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    LQR
    PMA / PMN Number
    K946358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULT: (NO FAILURE DETECTED) WAS USED; HOWEVER, THE WORKING LENGTH WAS FOUND TO BE TWISTED. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH TWISTED. FUNCTIONAL EVALUATION FOUND THE DEVICE TO BE WITH IN SPECIFICATION WITH RESPECT TO ELECTRICAL FUNCTIONALITY. THE COMPLAINT THAT THE STONETOME FAILED TO CUT WAS UNABLE TO BE CONFIRMED. THE DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE, NOR ANY ISSUE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA VATER DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE A CONTRAST STUDY WAS PERFORMED INSIDE THE BILE DUCT USING A CANNULA. A GUIDEWIRE WAS INSERTED TO THE BILE DUCT AND THEN A STONETOME WAS ADVANCED TO THE PAPILLA. WHEN THE PHYSICIAN ATTEMPTED TO SECTION THE PAPILLA THE ELECTRICAL CURRENT WAS UNABLE TO BE DELIVERED. NO ISSUE WAS REPORTED WITH THE GENERATOR. REPORTEDLY, THERE WAS NO VISUAL DAMAGE NOTED WITH THIS DEVICE. A SECOND STONETOME AND THE SAME ACTIVE CORD WERE USED TO COMPLETE THE PROCEDURE. THE EST WAS COMPLETED WITHOUT ISSUE AND A STONE WAS REMOVED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE PAPILLA VATER DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE A CONTRAST STUDY WAS PERFORMED INSIDE THE BILE DUCT USING A CANNULA. A GUIDEWIRE WAS INSERTED TO THE BILE DUCT AND THEN A STONETOME WAS ADVANCED TO THE PAPILLA. WHEN THE PHYSICIAN ATTEMPTED TO SECTION THE PAPILLA THE ELECTRICAL CURRENT WAS UNABLE TO BE DELIVERED. NO ISSUE WAS REPORTED WITH THE GENERATOR. REPORTEDLY, THERE WAS NO VISUAL DAMAGE NOTED WITH THIS DEVICE. A SECOND STONETOME AND THE SAME ACTIVE CORD WERE USED TO COMPLETE THE PROCEDURE. THE EST WAS COMPLETED WITHOUT ISSUE AND A STONE WAS REMOVED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326295 STONETOME? DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00535210 16526878

    Patients

    Seq Age Sex Outcome Treatment
    1