BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2123363 · Received June 10, 2011

    Report

    Report Number
    9681834-2011-00026
    Event Type
    Malfunction
    Date Received
    June 10, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS/CONCLUSIONS: BASED UPON EVAL OF USER FACILITY INFO AND RETURNED SAMPLE; BASED UPON EVAL OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE INVOLVED DEVICE WAS RETURNED AND EVALUATED BY QA AT THE MFG FACILITY. EXAMINATION CONFIRMED: THE POLYURETHANE COATING HAD BEEN PARTIALLY SHEARED-OFF THE 29MM PORTION OF THE GUIDEWIRE STARTING FROM A POINT APPROX 945MM FROM THE DISTAL END; THE COATING WAS THEN ROLLED BACK ON ITSELF IN THE DISTAL DIRECTION EXPOSING THE CORE WIRE, THE EDGES OF THE BROKEN URETHANE COATING APPEARED TO HAVE BEEN RIPPED; MEASUREMENT CONFIRMED 3MM OF THE COATING HAD BEEN COMPLETELY DETACHED. INSPECTION AND TESTING OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONFIRMED NO EVIDENCE OF PRE-EXISTING DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BE REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURNED SAMPLE ARE MOST CONSISTENT WITH DAMAGE TO THE GLIDEWIRE DUE TO EXCESSIVE MANIPULATION AGAINST RESISTANCE DURING THE PROCEDURE (I.E. AFTER THE GUIDEWIRE REPORTEDLY "BECAME STUCK" IN THE CATHETER). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PART OF THE GLIDEWIRE'S COATING WAS "SEPARATED" WHEN THE PHYSICIAN WAS PULLING THE GUIDEWIRE BACK THROUGH AN OMNI FLUSH CATHETER. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT: THE GUIDEWIRE "BECAME STUCK" IN THE CATHETER; UPON REMOVAL OF THE WIRE, THE PHYSICIAN NOTED THAT THE COATING HAD BEEN DETACHED FROM THE WIRE; NO MATERIAL WAS LEFT IN THE PT; AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER GUIDEWIRE OF THE SAME TYPE WITH NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORP., ASHITAKA NA 101119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OMNI FLUSH CATHETER