BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOCATCH IMMOBILIZATION DEVICE

    MDR report key: 2013196 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00664
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE OUTER SHEATH AND WIRE SUB-ASSEMBLY KINKED AND BUCKLED. THE HANDLE CANNULA WAS KINKED AND BROKEN. THE HANDLE CANNULA WAS NOT SEATED PROPERLY IN THE PINCH VISE AND BOTH HEAT-SHRINKS WERE BENT. FUNCTIONALLY THE BASKET WOULD NOT CLOSE WHEN THE HANDLE WAS ACTUATED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS DEFECTIVE. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO LIMIT PRODUCT PERFORMANCE ISSUES, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCATCH IMMOBILIZATION DEVICE FAILED AND IT DIDN'T WORK DURING A STONE REMOVAL PROCEDURE. THE EVENT DATE REPORTED TO BE (B)(6), 2011. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCATCH IMMOBILIZATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCATCH IMMOBILIZATION DEVICE FAILED AND IT DIDN'T WORK DURING A STONE REMOVAL PROCEDURE. THE EVENT DATE REPORTED TO BE (B)(6), 2011. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCATCH IMMOBILIZATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOCATCH IMMOBILIZATION DEVICE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - SPENCER M0068404120 12881847

    Patients

    Seq Age Sex Outcome Treatment
    1