BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME RX SPHINCTEROTOME

    MDR report key: 2142270 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02244
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: RECEIVED ADDITIONAL INFORMATION ON (B)(6), 2011 THAT THE UPN OF THE DEVICE WAS (B)(4). A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH WAS TWISTED AND KINKED, THE EXTRUSION (DISTAL END) WAS BENT AND THE DISTAL TIP WAS CRACKED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THAT THE DISTAL TIP WAS BENT AND CRACKED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE CONDITION OF THE DEVICE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS INSERTED THROUGH THE OLYMPUS 180 ENDOSCOPE. HOWEVER, WHEN THE DEVICE WAS ADVANCED FROM THE END OF THE ENDOSCOPE BEFORE IT WAS INSERTED INTO THE AMPULLA OF THE COMMON BILE DUCT, IT WAS DISCOVERED THAT THE DISTAL TIP WAS BENT AND CRACKED. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS INSERTED THROUGH THE OLYMPUS 180 ENDOSCOPE. HOWEVER, WHEN THE DEVICE WAS ADVANCED FROM THE END OF THE ENDOSCOPE BEFORE IT WAS INSERTED INTO THE AMPULLA OF THE COMMON BILE DUCT, IT WAS DISCOVERED THAT THE DISTAL TIP WAS BENT AND CRACKED. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00573080

    Patients

    Seq Age Sex Outcome Treatment
    1