BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 2 0CM

    MDR report key: 2243878 · Received August 24, 2011

    Report

    Report Number
    1036844-2011-00274
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    May 19, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SWG WAS RETURNED FOR ANALYSIS. NO SYRINGE OR INTRODUCER NEEDLE WAS RETURNED. THE SWG WAS UNRAVELED AT THE DISTAL END. THERE WERE SEVERAL KINKS IN THE SWG. THERE WERE NO CENTIMETER MARKINGS ON THE SWG. DISCOLORATION WAS OBSERVED AT THE BROKEN END OF THE CORE WIRE. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE SWG IN THE AREA OF THE BREAK. THE DISTAL WELD WAS MISSING FROM THE COIL WIRE. THE PROXIMAL WELD WAS INTACT. THE OUTSIDE DIAMETER (OD) OF THE SWG WAS MEASURED AT THE PROXIMAL END WHERE IT WAS NOT UNRAVELED AND DID NOT AGREE WITH THE SPECIFICATION. THE RETURNED SWG DID NOT MATCH THE SWG SUPPLIED IN KIT CS-25703-E; HOWEVER, A .035¿ WIRE SHOULD ALSO FIT THROUGH THE ARROW RAULERSON SYRINGE (ARS) AND INTRODUCER NEEDLE. THE INSTRUCTION BOOKLET PROVIDED WITH THE KIT 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 SWG. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED IN THE SWG, THE ARS AND THE INTRODUCER NEEDLE. THERE WERE NO RELEVANT FINDINGS ON THE SWG AND THE INTRODUCER NEEDLE. THERE WAS A POTENTIALLY RELEVANT FINDING ON THE ARS FOR INNER CANNULA INNER DIAMETER (ID) BLOCKED/CONSTRICTED. A NONCONFORMANCE WAS INITIATED TO INVESTIGATE THE POTENTIALLY RELEVANT FINDING. THE REPORT THAT THE SWG KINKED WAS CONFIRMED THROUGH EXAM OF THE RETURNED SAMPLE. IN ADDITION TO BEING KINKED, THE SWG WAS UNRAVELED AND THE DISTAL WELD WAS MISSING. THE ARS AND SYRINGE INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVAL. THE POTENTIAL CAUSE OF THIS ISSUE COULD NOT BE DETERMINED BASED ON THE SAMPLE AND INFO PROVIDED AND WITHOUT ALL THE COMPONENTS INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS MET WHEN ADVANCING THE SPRING WIRE GUIDE (SWG) INTO THE PT¿S SUBCLAVIAN VEIN. AS A RESULT, THE MD REMOVED IT FROM THE SYRINGE, AT WHICH TIME THE SWG WAS FOUND KINKED. THE MD THEN OPENED A NEW KIT TO FINISH THE PROCEDURE; HOWEVER, AFTER THE NEW CATHETER WAS PLACED, HE WAS UNABLE TO WITHDRAW THE SWG. REFERENCE MDR #9680794-2011-00055 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS. FOZ ARROW INTL., INC. RF1010659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK