BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND PROBE

    MDR report key: 11602012 · Received April 1, 2021

    Report

    Report Number
    3005099803-2021-01244
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 19, 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, 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 · 0

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01244 FOR THE LITHOCLAST ULTRASOUND PROBE, MFR REPORT #3005099803-2021-01245 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01247 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 1, 2021: DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. 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. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE.

    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 FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. THE LITHOCLAST ULTRASOUND PROBE, MFR REPORT #3005099803-2021-01245 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01247 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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
    499291 ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION M0068407170 0026187849 08714729516613

    Patients

    Seq Age Sex Outcome Treatment
    1