BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME? RX 49

    MDR report key: 3042609 · Received April 9, 2013

    Report

    Report Number
    3005099803-2013-02485
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: CATHETER TORN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THERE WERE SEVERAL TWISTS ALONG THE WORKING LENGTH, THE DISTAL TIP WAS SEVERELY BLACKENED AND THE WORKING LENGTH (CATHETER) IS TORN AT THE DISTAL TIP. THE RAPID EXCHANGE LENGTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS; IT WAS THIS SECTION OF THE WORKING LENGTH THAT WAS TORN, FROM THE END OF THE OPEN C-CHANNEL TO THE TIP OF THE DEVICE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT SINCE MANIPULATION OF THE DEVICE DURING THE PROCEDURE COULD HAVE CAUSED THE FAILURES FOUND. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WIRE FELL OUT OF THE GUIDEWIRE CHANNEL BECAUSE THE CHANNEL WAS SPLIT ALL THE WAY TO THE TIP OF THE DEVICE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WIRE FELL OUT OF THE GUIDEWIRE CHANNEL BECAUSE THE CHANNEL WAS SPLIT ALL THE WAY TO THE TIP OF THE DEVICE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145117 JAGTOME? RX 49 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00573500 15638058

    Patients

    Seq Age Sex Outcome Treatment
    1