BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.3 MM X 403 MM ULTRASOUND PROBE

    MDR report key: 3782130 · Received April 30, 2014

    Report

    Report Number
    3005099803-2014-01836
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K012445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF ¿PROBE BROKE.¿ ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION CONFIRMED THAT THE RETURNED DEVICE WAS BROKEN AT APPROXIMATELY 5.2 CM FROM THE HUB AND THE WORKING LENGTH OF THE DEVICE WAS NOT BENT BUT PRESENTED NUMEROUS AREAS OF SCRATCHED AND SLIGHTLY DARKENED AREAS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED; THEREFORE, THE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT 3005099803-2014-01835 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED FOR A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE AND SHEARED COMPLETELY ABOUT 3 INCHES FROM ITS BASE AND FELL INSIDE THE PATIENT. REPORTEDLY, TINY METAL SHAVINGS ALSO FELL INSIDE THE PATIENT; THE ULTRASOUND SETTING WAS PLACED AT 70 PERCENT POWER. THE PHYSICIAN USED A GRASPER TO RETRIEVE THE DETACHED PROBE AND METAL SHAVINGS. ANOTHER ULTRASOUND PROBE (MFR REPORT 3005099803-2014-01835) WAS USED AND SAME ISSUE OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT 3005099803-2014-01835 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED FOR A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE AND SHEARED COMPLETELY ABOUT 3 INCHES FROM ITS BASE AND FELL INSIDE THE PATIENT. REPORTEDLY, TINY METAL SHAVINGS ALSO FELL INSIDE THE PATIENT; THE ULTRASOUND SETTING WAS PLACED AT 70 PERCENT POWER. THE PHYSICIAN USED A GRASPER TO RETRIEVE THE DETACHED PROBE AND METAL SHAVINGS. ANOTHER ULTRASOUND PROBE (MFR REPORT 3005099803-2014-01835) WAS USED AND SAME ISSUE OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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
    260971 3.3 MM X 403 MM ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - SPENCER M0068407160 16646291

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention