BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRING WIRE GUIDE COMPONENT

    MDR report key: 1884219 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00088
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    February 6, 2009
    Report Date
    April 1, 2010
    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

    (B)(4). THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES OF (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR # 1036844-2009-00062, MDR # 1036844-2010-00089. UNTIL (B)(4) 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(4) 2009 THROUGH (B)(4) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, THE SPRING WIRE GUIDE (SWG) KINKED WHEN BEING ADVANCED THROUGH THE ARROW RAULERSON SYRINGE (ARS) AT APPROX 2-3CM. THE CLINICIAN REPORTED MEETING WITH THIS ISSUE WITH A TOTAL OF THREE PACKAGES ON THE SAME PT. THE INSERTION WAS FINALLY SUCCESSFUL WITH THE FOURTH PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING WIRE GUIDE COMPONENT ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. CF8111835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK