BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2142296 · Received June 17, 2011

    Report

    Report Number
    9681834-2011-00028
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NON-RESORBABLE MATERIAL UNRETRIEVED IN THE BODY. BASED ON EVALUATION OF USER FACILITY INFORMATION; BASED UPON EVALUATION OF RESERVE SAMPLES. THE INVOLVED SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION SO THE EXTENT OF DAMAGE TO THE GUIDEWIRE CANNOT BE CONFIRMED. AS STATED, THE USER FACILITY REPORTED THAT A PIECE OF THE "HYDROPHILIC COATING" WAS SHEARED OFF THE DISTAL PORTION OF THE GUIDEWIRE. EXAMINATION AND TESTING OF A RETAINED SAMPLE FROM THE SAME LOT CONFIRMED THERE WERE NO INDICATIONS OF MALFUNCTION OR PRE-EXISTING DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION IS MOST CONSISTENT WITH DAMAGE TO THE GLIDEWIRE DUE TO MANIPULATION AGAINST A SHARP, METALLIC SURFACE (SUCH AS THE METAL INTRODUCER NEEDLE THAT WAS REPORTEDLY USED). ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN FILED BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE COATING WAS SHEARED OFF A GUIDEWIRE DURING A PROCEDURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE WIRE WAS WITHDRAWN THROUGH A METAL INTRODUCER NEEDLE; DURING REMOVAL A PIECE OF THE HYDROPHILIC COATING SHEARED OFF THE DISTAL PORTION OF THE GUIDEWIRE; THE DETACHED MATERIAL WAS LOCATED IN THE ANKLE OF THE PATIENT THROUGH X-RAY; AND THE DECISION WAS MADE TO NOT RETRIEVE THE DETACHED MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORP, ASHITAKA NA 101118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other METAL INTRODUCER NEEDLE