BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSTICK? II

    MDR report key: 4242402 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06777
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED ONE ACCUSTICK OUTER SHEATH AND PRECOAT .038 'J' STIFF GUIDEWIRE WITH RESIDUE PRESENT ON THE DEVICE INDICATING USE/ HANDLING. THE ACCUSTICK DILATOR AND STIFFENER WERE NOT RETURNED. A PHYSICAL EXAMINATION OF THE ACCUSTICK SHEATH FOUND IT TO BE BENT AT APPROXIMATELY 6CM FROM THE HUB AND THE TIP WAS TORN AND FOLDED INWARD. THE GUIDEWIRE WAS BENT AT 21 CM FROM THE STIFF END AND ALSO SEPARATED INTO 2 PIECES AT APPROXIMATELY 48.5CM FROM THE STIFF END. THE J-TIP WAS KINKED AND BUCKLED. A MAGNIFIED EXAMINATION OF THE GUIDEWIRE FRACTURED ENDS FOUND THE CORE WIRE OUTER DIAMETER WAS SLIGHTLY SMALLER AND THE MATERIAL HAD BEEN DEFORMED PRIOR TO FAILURE. THE MATERIAL ALSO APPEARED TO BE COLD-WORKED PRIOR TO FAILURE. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GUIDEWIRE BREAK OCCURRED. THE PATIENT WAS UNDERGOING A CR GUIDED INSERTION OF A PIGTAIL DRAIN IN AN UNSPECIFIED LOCATION. WHILE ADVANCING THE ACCUSTICK¿ II SHEATH OVER THE GUIDE WIRE, THE WIRE BROKE DISTALLY AND A 5-10CM PORTION OF THE WIRE INITIALLY REMAINED WITHIN THE COLLECTION. THE FOLLOWING DAY, FLUOROSCOPIC REMOVAL OF THE RETAINED WIRE WAS PERFORMED AND THE WIRE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GUIDEWIRE BREAK OCCURRED. THE PATIENT WAS UNDERGOING A CR GUIDED INSERTION OF A PIGTAIL DRAIN IN AN UNSPECIFIED LOCATION. WHILE ADVANCING THE ACCUSTICK II SHEATH OVER THE GUIDE WIRE, THE WIRE BROKE DISTALLY AND A 5-10CM PORTION OF THE WIRE INITIALLY REMAINED WITHIN THE COLLECTION. THE FOLLOWING DAY, FLUROSCOPIC REMOVAL OF THE RETAINED WIRE WAS PERFORMED AND THE WIRE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727453 ACCUSTICK? II INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER M001207020 17086347

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention