BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 13 CM

    MDR report key: 2480395 · Received February 28, 2012

    Report

    Report Number
    1036844-2012-00050
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 4, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IT IS REPORTABLE. DEVICE EVALUATION: RETURNED WERE ONE GUIDE WIRE AND AN ADVANCER. NO CATHETER WAS RETURNED. THE GUIDE WIRE WAS UNRAVELED AT THE DISTAL END EXCEPT FOR THE LAST 13 COILS. THE CORE WIRE WAS SEPARATED ADJACENT TO THE WELD AT THE DISTAL END. DISCOLORATION WAS OBSERVED AT THE BROKEN END OF THE CORE WIRE, WHICH IS CONSISTENT WITH PROXIMITY TO A WELD. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE WIRE IN THE AREA OF THE BREAK. THE PROXIMAL WELD WAS INTACT. THE CORE WIRE WAS MEASURED AND BASED UPON THE MEASURED LENGTH OF THE BROKEN CORE WIRE NO PIECES APPEAR TO BE MISSING. THE O.D. OF THE GUIDE WIRE WAS MEASURED AT THE PROXIMAL END AND MET SPECIFICATIONS. THE INSTRUCTION BOOKLET PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. IT STATES THAT IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE AFTER CATHETER PLACEMENT, THE GUIDE WIRE MAY BE KINKED ABOUT THE TIP OF THE CATHETER WITHIN THE VESSEL. IN THIS CASE IT IS RECOMMENDED TO WITHDRAW THE CATHETER RELATIVE TO THE GUIDE WIRE ABOUT 2-3 CM AND THEN ATTEMPT TO REMOVE THE GUIDE WIRE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE DEVICE HISTORY RECORDS FOR THE GUIDE WIRE AND CATHETER WERE REVIEWED WITH NO RELEVANT FINDINGS. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE REPORT THAT THE GUIDE WIRE TIP WAS DAMAGED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE WAS UNRAVELED NEAR THE DISTAL END. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE THAT EXCEEDS THE MINIMUM FORCE SPECIFIED BY THE ISO STANDARD FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. QUARTERLY TRENDING INDICATES A LOW, STABLE RATE FOR UNRAVELED OR SEPARATED GUIDE WIRE COMPLAINTS. BASED ON THESE CIRCUMSTANCES, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PATIENT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO REMOVE THE SWG AFTER THE CATHETER WAS PLACED. AS A RESULT, BOTH THE CATHETER AND SWG WERE REMOVED AS ONE IN THEIR ENTIRETY, AND A NEW KIT WAS OPENED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. UPON REMOVAL, THE SWG TIP WAS FOUND DAMAGED. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 4 FR X 13 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. RF0129384

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN