BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTICK¿ II

    MDR report key: 2213274 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03598
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE ACCUSTICK II SYSTEM .038 J WITH ORIGINAL LABEL AND WITH RESIDUE PRESENT ON THE DEVICE. THE RETURNED PRODUCT COMPRISED OF THE INNER AND OUTER SHEATH ASSEMBLIES. THE METAL STIFFENER (INNER CANNULA) ASSEMBLY WAS NOT RETURNED FOR EVALUATION. THE OUTER SHEATH WAS FOUND BROKEN INTO SEVEN PIECES. THE INNER SHEATH WAS FOUND SLIGHTLY KINKED NEAR THE MIDDLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE A CANNULA FRACTURED. THE PHYSICIAN WENT TO INSERT THE ACCUSTICK II SYSTEM .038 J IN TO THE INTRODUCER AND THE CANNULA FRACTURED IN HER HAND. IT BROKE AT THE STYLET AND FRACTURED IN MULTIPLE AREAS ALONG THE CANNULA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE A CANNULA FRACTURED. THE PHYSICIAN WENT TO INSERT THE ACCUSTICK II SYSTEM .038 J IN TO THE INTRODUCER AND THE CANNULA FRACTURED IN HER HAND. IT BROKE AT THE STYLET AND FRACTURED IN MULTIPLE AREAS ALONG THE CANNULA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSTICK¿ II INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER M001207020 12867840

    Patients

    Seq Age Sex Outcome Treatment
    1