BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 2903892 · Received December 3, 2012

    Report

    Report Number
    1319211-2012-00242
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K914199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE SOFTVU 4FX65CM .035NB CATHETER. A VISUAL EXAMINATION NOTED THAT CATHETER SHAFT WAS BROKEN APPROXIMATELY 1.5 CM FROM THE TIP MATERIAL. THE CATHETER SHAFT SHOWED SIGNS OF BEING STRETCHED DUE TO A SIDE HOLE SHOWING SIGNS OF ELONGATION. THE TIP MATERIAL SHOWED SIGNS OF BEING STRETCHED AS WELL. THE GUIDEWIRE USED IN THE PROCEDURE WAS NOT RETURNED. MEASUREMENTS OF THE CATHETER MET SPECIFICATIONS. THE CUSTOMER'S COMPLAINT DESCRIPTION IS CONFIRMED. ALTHOUGH THE COMPLIANT IS CONFIRMED THE ROOT CAUSE CANNOT BE DETERMINED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS THAT AS THE PHYSICIAN WAS ADVANCING THE GUIDEWIRE THROUGH THE CATHETER RESISTANCE WAS MET; THE PHYSICIAN THEN USED EXCESSIVE FORCE IN AN ATTEMPT TO FURTHER ADVANCE THE GUIDEWIRE. THIS CAUSED THE STRETCHING AND ELONGATION OF THE SOFT TIP NOTED ON THE RETURNED SAMPLE. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT; "NEVER ADVANCE OR RETRACT AN ANGIOGRAPHIC CATHETER OR GUIDEWIRE AGAINST RESISTANCE. THIS MAY RESULT IN DAMAGE TO THE VESSEL, THE PRODUCT, OR BOTH". A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2012, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN UNSPECIFIED PROCEDURE. THE ATTENDING PHYSICIAN SUCCESSFULLY REMOVED THE CATHETER FROM THE PATIENT, AND WHEN REMOVING THE WIRE FROM THE CATHETER, THE CATHETER FRACTURED. AS THE EVENT HAPPENED OUTSIDE OF THE PATIENT BODY, THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. THE REPORTED FAILED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS 578069

    Patients

    Seq Age Sex Outcome Treatment
    1