BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C)

    MDR report key: 1994263 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00027
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    June 25, 2010
    Report Date
    January 13, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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: RETURNED WERE 2 SWG'S, 2 ADVANCERS AND ONE ARS. SAMPLE A SWG WAS STUCK IN THE ARS WITH A SMALL KINKED/TWISTED PORTION PROTRUDING FROM THE TIP OF THE ARS. THERE WERE DISPLACED COILS IN THE DISTAL PORTION OF THE SWG CONSISTENT WITH EITHER WITHDRAWING THE SWG THROUGH THE NEEDLE OR ADVANCING THE NEEDLE WHILE THE SWG WAS STILL THROUGH THE TIP OF THE NEEDLE. SAMPLE B WAS BENT AND KINKED AT THE DISTAL END. AS RECEIVED, THE PLUNGER WAS PULLED OUT ON SAMPLE A. THE PLUNGER WAS PUSHED FORWARD EXPOSING MORE OF THE SWG. AN ATTEMPT WAS MADE TO PUSH THE SWG THROUGH THE DISTAL TIP OF THE ARS, BUT IT ONLY ADVANCED A SHORT DISTANCE AND WOULD NOT MOVE ANY FURTHER. IT WAS OBSERVED THAT PART OF THE COIL WIRE THAT WAS NOW EXPOSED WAS UNRAVELED. THE CORE WIRE WAS NOT VISIBLE ON THE SWG PROTRUDING FROM THE DISTAL TIP OF THE ARS INDICATING THAT IT HAD BROKEN NEAR THE DISTAL TIP. THE COILS WERE OBSERVED TO BE STRETCHED APART ON THE SWG PROTRUDING FROM THE PROXIMAL END OF THE ARS AND THE CORE WIRE WAS VISIBLE THROUGH THE COILS. IT WAS NOT POSSIBLE TO REMOVE THE SWG FROM THE ARS WITHOUT DAMAGING IT FURTHER. THE OD'S OF SAMPLE A AND B BOTH MET SPECIFICATION. SAMPLE B WAS MEASURED AND LENGTH WAS CONSISTENT WITH THE SPECIFICATIONS FOR THIS KIT. INSTRUCTIONS FOR USE DESCRIBE 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 CONDUCTED BASED ON SALES HISTORY, WITH NO RELEVANT FINDINGS. ALSO, THERE HAVE BEEN NO MATERIAL CHANGES IN THE SWG THAT WOULD AFFECT STIFFNESS. THE REPORT OF SWG'S BENDING DURING INSERTION WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. BASED ON THE DISPLACED COILS IN THE SAMPLE AND THE REPORT OF DIFFICULTY WITH THE SWG ON OBESE PTS, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY HAVE NOTICED THE SPRING WIRE GUIDE (SWG) BENDS AND DOES NOT PASS THROUGH THE NEEDLE EVEN WHEN TRYING ADD'L ATTEMPTS WITH NEW SWG'S. THE SWG DOESN'T HAVE ENOUGH STIFFNESS FOR OBESE PTS. WHEN REACHING THE SOFT TISSUE, THE NEEDLE WON'T PULL OVER THE SWG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C) ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK