BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-TIME RETRIEVAL DEVICE

    MDR report key: 1832159 · Received September 13, 2010

    Report

    Report Number
    2939204-2010-00940
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MMX
    PMA / PMN Number
    K014109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED, THE PHYSICIAN REPORTED THAT THE ROTATION OF THE GUIDEWIRE CAUSED IT TO BREAK WHICH NECESSITATED USE OF THE RETRIEVAL BASKET. IN ADDITION, CONTINUOUS FLUSH WAS MAINTAINED, THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY AND NO PIECES WERE LEFT INSIDE THE PATIENT. VISUAL ANALYSIS OF THE RETURNED RETRIEVAL BASKET REVEALED THE TIP LENGTH SECTION THAT INCLUDES THE COIL WAS MISSING AND HAD NOT BEEN RETURNED. NO OTHER ANOMALIES WERE NOTED. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THE DEVICE WAS USED AGAINST INSTRUCTIONS FOR USE. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE GUIDEWIRE BROKE DURING REPOSITIONING. WHILST ATTEMPTING TO REMOVE THE BROKEN GUIDEWIRE, THE RETRIEVAL BASKET ALSO BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE GUIDEWIRE BROKE DURING REPOSITIONING. WHILST ATTEMPTING TO REMOVE THE BROKEN GUIDEWIRE, THE RETRIEVAL BASKET ALSO BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-TIME RETRIEVAL DEVICE DEVICE, PERCUTANEOUS RETRIEVAL MMX BOSTON SCIENTIFIC - CORK M0039110040 12267444

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)