BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 3 0CM

    MDR report key: 2052054 · Received March 2, 2011

    Report

    Report Number
    1036844-2011-00069
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 23, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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: ONE SWG WAS RETURNED FOR EVALUATION. THE ARS WAS NOT RETURNED FOR EVALUATION. THE SWG WAS UNRAVELED APPROXIMATELY 51.6 CM FROM THE DISTAL TIP. THE CORE WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE MEASURED LENGTH OF THE BROKEN CORE WIRE, NO PIECES APPEARED TO BE MISSING. THE OUTSIDE DIAMETER OF THE SWG WAS MEASURED AND WAS WITHIN SPECIFICATION. A BEND WAS OBSERVED AT THE DISTAL END APPROXIMATELY 1.8 CM FROM THE DISTAL TIP. MICROSCOPIC EXAMINATION REVEALED THE CORE WIRE BROKE ADJACENT TO THE PROXIMAL WELD. BOTH DISTAL AND PROXIMAL WELDS ARE INTACT WITH NO ABNORMALITIES. THE INSTRUCTIONS FOR USE DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF SWG DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE SWG AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE DEVICE HISTORY RECORDS FOR THE SWG WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. A RISK EVALUATION HAS BEEN COMPLETED FOR THIS ISSUE AND THE RECOMMENDATION IS TO CONTINUE TO MONITOR THE COMPLAINTS. NO ADDITIONAL ACTION IS NEEDED. THE REPORT OF A SWG AND ARS RESISTANCE IS CONFIRMED THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLE. THE CORE WIRE WAS FOUND TO BE BROKEN ADJACENT TO THE WELD. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF SWG KINKING. SWG BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. 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 WHEN ADVANCING THE SPRING WIRE GUIDE (SWG) THROUGH THE ARROW RAULERSON SYRINGE (ARS), THE SWG BECAME STUCK. UPON REMOVING THE SWG, THE WIRE WAS FOUND TO HAVE KINKED. 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: 3-LUMEN 7FR X 3 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF9127499

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN