BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTOUCH HEADHUNTER CATHETER

    MDR report key: 1012502 · Received March 12, 2008

    Report

    Report Number
    1628221-2008-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    January 7, 2008
    Report Date
    January 28, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE UNIT WAS RETURNED FOR EVAL. THE SUBJECT DEVICE WAS VISUALLY EXAMINED. THERE WERE SEVERAL KINKS OBSERVED ALONG THE LENGTH OF THE CATHETER SHAFT. THE COMPLAINANT REPORTED THAT THEY WERE USING THE CATHETER TO INTRODUCE COILS AND HAD DIFFICULTY. MERIT'S DEVICE IS NOT INTENDED FOR THE INTRODUCTION OF COILS AS INDICATED IN THE INSTRUCTIONS FOR USE. THE INDICATIONS STATE: "ANGIOGRAPHIC CATHETERS ARE DESIGNED TO BE USED FOR DELIVERING RADIOPAQUE MEDIA TO SELECTED SITES IN THE VASCULAR SYSTEM IN CONJUNCTION WITH ROUTINE DIAGNOSTIC PROCEDURES. ANGIOGRAPHIC CATHETERS WITH MARKER BANDS MAY ALSO BE USED FOR ANATOMICAL MEASUREMENTS." IT IS POSSIBLE THAT MISUSE CAUSED THE CATHETER TO KINK. HOWEVER, THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER HAD DIFFICULTY INTRODUCING A .035" COIL INSIDE THE CATHETER. THEY TRIED TWO DIFFERENT COILS FROM TWO DIFFERENT SUPPLIERS. PLEASE NOTE THAT UPON EXAMINATION OF THE SUBJECT DEVICE AFTER IT WAS RETURNED, A DIFFERENT FAILURE MODE WAS DISCOVERED, DEEMING THIS A REPORTABLE EVENT. THE CATHETER WAS KINKED INSIDE THE PT. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT. THE DATE OF OBTAINING NEW INFO WAS 2-28-2008. THEREFORE, THIS REPORT IS SUBMITTED WITHIN THE 30 DAY REQUIREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTOUCH HEADHUNTER CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST| COILS| SALINE