BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND PROBE

    MDR report key: 11601682 · Received April 1, 2021

    Report

    Report Number
    3005099803-2021-01231
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 20, 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

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01230 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01231 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE. THE PHYSICIAN NOTED THAT THE HANDPIECE WAS HOT AND THE HANDPIECE WAS TRANSFERRING HEAT TO THE PROBE AT THE CONNECTION SITE, POTENTIALLY MAKING THE PROBES WEAKER AND CONTRIBUTING TO THEIR BREAK. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A THIRD LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON APRIL 1, 2021. DURING THE PROCEDURE, THE TWO ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PHYSICIAN NOTED THAT THE HANDPIECE WAS HOT AND THE HANDPIECE WAS TRANSFERRING HEAT TO THE PROBE AT THE CONNECTION SITE, POTENTIALLY MAKING THE PROBES WEAKER AND CONTRIBUTING TO THEIR BREAK. THE PROBES BROKE AT THEIR PROXIMAL END NEAR THE JUNCTION WITH THE HANDPIECE (AND NEAR THE PROXIMAL END OF THE NEPHOSCOPE). THE PIECE THAT BROKE OFF OF EACH 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.

    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

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01230 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE. THE PHYSICIAN NOTED THAT THE HANDPIECE WAS HOT AND THE HANDPIECE WAS TRANSFERRING HEAT TO THE PROBE AT THE CONNECTION SITE, POTENTIALLY MAKING THE PROBES WEAKER AND CONTRIBUTING TO THEIR BREAK. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A THIRD LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499398 ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION M0068407170 0026111621 08714729516613

    Patients

    Seq Age Sex Outcome Treatment
    1