BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTICK? II

    MDR report key: 4169481 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06353
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED ONE ACCUSTICK II WITH ORIGINAL, OPENED, AND LABELED POUCH WAS RECEIVED. NO VISIBLE RESIDUE WAS FOUND ON THE EXTERNAL SURFACES OF THE DEVICE. THE ENTIRE WORKING LENGTH WAS BENT. THE NEEDLE CANNULA WAS PROTRUDING OUT OF THE DILATOR AND SHEATH APPROXIMATELY 1.4CM FROM THE DISTAL END OF THE SHEATH. THE DISTAL TIP OF THE SHEATH WAS DEFORMED. THE NEEDLE CANNULA WAS REMOVED FROM THE DILATOR AND SHEATH; IT WAS BENT AND COVERED IN DRIED RESIDUE. THE DILATOR WAS REMOVED FROM THE SHEATH; IT WAS COVERED IN DRIED RESIDUE AND THE TIP WAS DEFORMED. THE DRIED RESIDUE WAS CONSISTENT WITH BODILY FLUIDS. 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 A RENAL ACCESS PROCEDURE, THE DILATOR WAS PROTRUDING THROUGH THE SHEATH. THE PHYSICIAN WAS USING A ACCUSTICK II SYSTEM .038 J TO ACCESS THE RENAL ARTERY. ONCE INSERTED INTO THE PATIENT, THEY NOTICED THAT THE DILATOR WAS PROTRUDING THROUGH THE SHEATH. THEY COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RENAL ACCESS PROCEDURE, THE DILATOR WAS PROTRUDING THROUGH THE SHEATH. THE PHYSICIAN WAS USING A ACCUSTICK II SYSTEM .038 J TO ACCESS THE RENAL ARTERY. ONCE INSERTED INTO THE PATIENT, THEY NOTICED THAT THE DILATOR WAS PROTRUDING THROUGH THE SHEATH. THEY COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648763 ACCUSTICK? II INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER M001207020 17163266

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR