BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND PROBE

    MDR report key: 11602015 · Received April 1, 2021

    Report

    Report Number
    3005099803-2021-01248
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    January 14, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFK
    UDI-DI
    08714729516613
    PMA / PMN Number
    K012445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE HANDPIECE WAS HOT AS WELL AS THE AT THE PROBE CONNECTION SITE. THE ULTRASOUND PROBE BROKE, 350 MILLIMETERS DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A NEW LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 1, 2021: DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBE BROKE AT THE PROXIMAL END NEAR THE JUNCTION WITH THE HANDPIECE (AND NEAR THE PROXIMAL END OF THE NEPHOSCOPE). THE PIECE THAT BROKE OFF OF THE PROBE WAS APPROXIMATELY 35 CM LONG. IT WAS REPORTED THAT THERE WAS STILL PLENTY OF LENGTH OUTSIDE THE PATIENT FOR THE PHYSICIAN TO GRAB AND REMOVE THE ENTIRE LENGTH OF THE BROKEN PIECE. A NEW LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE HANDPIECE WAS HOT AS WELL AS THE AT THE PROBE CONNECTION SITE. THE ULTRASOUND PROBE BROKE, 350 MILLIMETERS DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A NEW LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499289 ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION 840-717 0026111621 08714729516613

    Patients

    Seq Age Sex Outcome Treatment
    1