BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2243439 · Received August 18, 2011

    Report

    Report Number
    9681834-2011-00050
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Report Date
    February 17, 2011
    Manufacturer
    TERUMO CAORP, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K910722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFO SECTION OF THE UF MEDWATCH REPORT STATES: "IT WAS REPORTED THAT THE GLIDEWIRES WERE PASSED THROUGH A NEEDLE RATHER THAN THE SHEATH. EDUCATION TO BE PROVIDED." INSPECTION AND TESTING OF RETAINED SAMPLE FROM THE REPORTED LOT CONFIRMED THAT THERE WERE NO 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 BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE LIMITED INFO AVAILABLE, THE INFO PROVIDED ON THE UF MEDWATCH REPORT IS CONSISTENT WITH DAMAGE TO THE POLYURETHANE COATING DUE TO MANIPULATION OF THE GLIDEWIRE AGAINST A HARD, SHARP SURFACE (SUCH AS THE BEVEL OF THE ACCESS NEEDLE THROUGH WHICH THE GUIDEWIRE WAS REPORTEDLY PASSED). THE POTENTIAL THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN DAMAGE OR SEPARATION OF THE POLYURETHANE COATING IS ADDRESSED IN THE DEVICE LABELING. SPECIFIC STATEMENTS IN THE WARNINGS/PRECAUTIONS SECTION INCLUDE: "DO NOT MANIPULATE/WITHDRAW THE GLIDEWIRE THROUGH A METAL NEEDLE/METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL NEEDLE/METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL"; AND "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE GLIDEWIRE, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GLIDEWIRE." ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING AND F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PORTION OF THE COATING "APPEARED SHEARED OFF" AFTER REMOVAL DURING A PROCEDURE IN THE LOWER EXTREMITY. PER THE ATTACHED USER FACILITY MEDWATCH REPORT # (B)(4), THE EVENT IS DESCRIBED AS FOLLOWS: "THE SURGEON LOCATED THE PROFUNDA AND AFTER SEEING A FLUSH OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AT THE TAKE OFF OF THE PROFUNDA, CROSSED THIS WITH THE GLIDEWIRES. WHEN THE SURGEON REMOVED THE GLIDEWIRE, THE OUTER COATING APPEARED SHEARED OFF. ANGIOGRAPHIC IMAGES WERE TAKEN WHICH VISUALIZED THE OUTER COATING IN THE SFA AND THE PROFUNDA. THE SURGEON PROCEEDED WITH AN OPEN SURGICAL INTERVENTION TO REMOVE THE GLIDEWIRE COATING FRAGMENTS. THE SURGEON REPORTED THAT THE PT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CAORP, ASHITAKA NA 100730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEEDLE