BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.3 MM X 330 MM ULTRASOUND PROBE

    MDR report key: 6138840 · Received December 1, 2016

    Report

    Report Number
    3005099803-2016-03784
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K974164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED LITHOCLAST ULTRASOUND PROBE REVEALED THAT THE DEVICE WAS BROKEN AT 4.7CM FROM THE HUB. THE PROBE WORKING LENGTH WAS FREE OF OBVIOUS KINKS AND BENDS. THE PROBE PRESENTS SIGNS OF OXIDATION IN SOME AREAS AND AN EXAMINATION OF THE DEVICE FOUND AREAS OF HEAVY SURFACE SCRATCHES IN SEVERAL LOCATIONS ALONG THE PROBE WORKING LENGTH. DUE TO THE HEAVY SCRATCHES IN SEVERAL LOCATIONS THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED FOR A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PROBE BROKE IN TWO PIECES AND FELL INSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN RETRIEVED THE BROKEN PIECES WITH AN INSTRUMENT. A RADIOGRAM (X-RAY) WAS PERFORMED TO CONFIRM THERE WERE PIECES LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED FOR A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(4) 2016 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PROBE BROKE IN TWO PIECES AND FELL INSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN RETRIEVED THE BROKEN PIECES WITH AN INSTRUMENT. A RADIOGRAM (X-RAY) WAS PERFORMED TO CONFIRM THERE WERE PIECES LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790234 3.3 MM X 330 MM ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - SPENCER M0068407140 18646982

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention