BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 9 FR

    MDR report key: 1711656 · Received May 26, 2010

    Report

    Report Number
    1036844-2010-00152
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    April 6, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EVAL: ONE USED SHEATH EXTENSION ASSEMBLY AND ONE SWG WERE RETURNED FOR EVAL. THE DILATOR WAS MISSING FROM THE SHEATH EXTENSION ASSEMBLY. THE SWG WAS PARTIALLY UNRAVELED AND HAD MULTIPLE KINKS. THE CORE WIRE WAS FOUND BROKEN ADJACENT TO THE DISTAL WELD; BOTH WELDS WERE INTACT AND NO PIECES APPEARED TO BE MISSING BASED ON THE MEASURED LENGTH OF THE BROKEN CORE WIRE. THE DIAMETER OF THE SWG WAS MEASURED AND WAS WITHIN THE SPECIFICATION. THE PRODUCT'S 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. THE INSTRUCTIONS BOOKLET ALSO DIRECTS THE USER TO THREAD THE TAPERED TIP OF THE DILATOR/SHEATH VALVE ASSEMBLY OVER THE SWG AND TO REMOVE THE SWG AND DILATOR AS A UNIT. THE INFO PROVIDED BY THE CUSTOMER DID NOT INDICATE WHEN THE DILATOR WAS REMOVED. THE REPORT THAT THE SWG AND SHEATH BECAME STUCK TOGETHER WAS CONFIRMED THROUGH VISUAL EXAM OF THE RETURNED SAMPLE. HOWEVER, NO MFG DEFECTS WERE FOUND DURING THIS INVESTIGATION. THIS SWG IS DESIGNED AND MFG TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO (B)(4) STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PT 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/PT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY WERE ATTEMPTING TO PLACE THE INTRODUCER INTO A (B)(6) MALE PT. THE INTRODUCER AND SPRING WIRE GUIDE (SWG) BECAME STUCK TOGETHER. AS A RESULT, THE INTRODUCER AND SWG WERE REMOVED AS ONE, AND ANOTHER KIT WAS USED. THE PT SUFFERED A MILD HEMATOMA AND THERE WERE NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 9 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. RF9085805

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR