BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME¿ RX 44

    MDR report key: 2222514 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02923
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE EXTRUSION AT THE DISTAL TIP WAS RIPPED FROM THE WIDE BROWN BAND (WHERE THE MANUFACTURED GUIDEWIRE CHANNEL ENDS) TO THE TIP. THE CLOSED EXTRUSION WAS TORN THROUGH THE DISTAL TIP AND THE TIP WAS SPLIT. FROM AN EXAMINATION OF THE DISTAL TIP, IT APPEARS THAT THE EXTRUSION WAS TORN WHEN THE USER ATTEMPTED TO REMOVE/SEPARATE THE GUIDEWIRE FROM THE SPHINCTEROTOME. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE OUTER SHEATH HAD BEEN TORN TO THE TIP OF THE DEVICE. SINCE THE DEVICES ARE 100% INSPECTED DURING MANUFACTURING, THE RIPPED WORKING LENGTH/TIP IS LIKELY DUE TO THE CUSTOMER USAGE/HANDLING DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 JAGTOME RX SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER OF THE DEVICE WAS TORN FROM THE C-CHANNEL TO THE TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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 JAGTOME RX SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER OF THE DEVICE WAS TORN FROM THE C-CHANNEL TO THE TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00573050

    Patients

    Seq Age Sex Outcome Treatment
    1