BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 2943897 · Received February 5, 2013

    Report

    Report Number
    9681834-2013-00014
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 28, 2012
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE DETACHED MATERIAL, BUT THERE IS NO CODE AVAILABLE. METHOD - (NO TESTING METHODS PERFORMED) - THE INVOLVED DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY AND THE LOT NUMBER IS UNKNOWN. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO A REVIEW OF USER FACILITY INFORMATION. AS NOTED ABOVE, DUE TO THE LACK OF THE INVOLVED DEVICE RETURN AND PRODUCT CODE / LOT NUMBER IDENTIFICATION, THE FAILURE INVESTIGATION WAS LIMITED TO A REVIEW OF INFORMATION PROVIDED BY THE USER FACILITY. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE LIMITED INFORMATION AVAILABLE, THE EVENT DESCRIPTION IS CONSISTENT WITH GUIDEWIRE DAMAGE DUE TO MANIPULATION AGAINST A HARD, SHARP SURFACE (SUCH AS METALLIC PORTION OF ANOTHER DEVICE, A CALCIFIED VASCULAR LESION, ETC.). THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT WITH STATEMENTS IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN DAMAGE AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING. SPECIFIC STATEMENTS INCLUDE THE FOLLOWING: (1) "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL"; (2) "MANIPULATE THE GLIDEWIRE SLOWLY AND CAREFULLY IN THE VESSEL WHILE CONFIRMING THE BEHAVIOR AND LOCATION OF THE WIRE'S TIP UNDER FLUOROSCOPY"; AND (3) "IF ANY RESISTANCE IS FELT, OR IF THE TIPS BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDEWIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." ALL 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

    USER FACILITY MEDWATCH REPORT # (B)(4) WAS RECEIVED BY THE MANUFACTURER ON (B)(4) 2013 FROM THE DISTRIBUTOR. PER THE USER FACILITY MEDWATCH REPORT, "WHILE SURGEON WAS INSERTING A PERMACATH FOR DIALYSIS UNDER FLUOROSCOPY, A FOREIGN OBJECT FOUND TO BE A PIECE FROM GLIDEWIRE WAS DISCOVERED AROUND THE PULMONARY ARTERY. THE PATIENT WAS TRANSFERRED TO A TERTIARY CARE CENTER SO THAT THE OBJECT COULD BE RETRIEVED." REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47907 RADIFOCUS GLIDEWIRE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R PERMACATH