BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 6IN (16 C

    MDR report key: 2181400 · Received July 6, 2011

    Report

    Report Number
    2242445-2011-00091
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    July 5, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    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 EVAL: ONE ARROW 7FR 16CM AGB+ CATHETER AND ONE MARKED SPRING WIRE GUIDE WITH J-TIP WAS RETURNED BY THE CUSTOMER FOR EVAL. THE SPRING WIRE GUIDE WAS INSIDE THE CATHETER PROTRUDING FROM THE DISTAL LUMEN OF THE CATHETER. THE SPRING WIRE GUIDE WAS UNRAVELED AT THE PROXIMAL END. THE CORE WIRE WAS SEPARATED ADJACENT TO THE WELD AT THE PROXIMAL END. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE WIRE IN THE AREA OF THE BREAK. THE DISTAL WELD WAS COMPLETELY INTACT. SEVERAL BENDS WERE OBSERVED IN THE CATHETER AND GUIDE WIRE; THE SAMPLES HAD A TWISTED APPEARANCE. THE SPRING WIRE GUIDE WAS REMOVED FROM THE CATHETER. THE SPRING WIRE GUIDE EXHIBITED SOME RESISTANCE DUE TO THE BENDS IN THE CATHETER AND THE GUIDE WIRE DURING REMOVAL. THE LENGTH OF THE CORE WIRE MEASURED 18" AND THE GUIDE WIRE OD MEASURED 0.792, 0.793, 0.794MM. THE LENGTH OF THE CATHETER BODY MEASURED 6 1/2". THE RETURNED SAMPLE MEASUREMENTS ARE WITHIN SPECIFICATION. BASED ON THE MEASURED LENGTH OF THE BROKEN CORE WIRE, NO PIECES OF CORE WIRE APPEAR TO BE MISSING. THE INSTRUCTION BOOKLET PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE DEVICE HISTORY RECORD REVIEW FOR THE SPRING WIRE GUIDE AND CATHETER WERE REVIEWED WITH NO RELEVANT FINDINGS. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MFG RELATED CAUSE. THE REPORT OF SWG/CATHETER RESISTANCE WAS CONFIRMED THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLES. THE CORE WIRE BROKE ADJACENT TO THE PROXIMAL WELD. NO MFG DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES ARE DESIGNED AND MFG TO WITHSTAND A TENSILE FORCE THAT EXCEEDS THE MINIMUM FORCE SPECIFIED BY THE ISO STANDARD FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PT 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/PT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO ADVANCE THE CATHETER OVER THE SPRING WIRE GUIDE (SWG) DURING INSERTION. AS A RESULT, THE PHYSICIAN REMOVED THE SWG AND CATHETER AND OPENED A NEW KIT WHICH WAS PLACED SUCCESSFULLY. IT IS UNK IF THERE WAS A DELAY IN TREATMENT. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 6IN (16 C ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. MF1017480

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK