BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M

    MDR report key: 11002306 · Received December 14, 2020

    Report

    Report Number
    9681834-2020-00249
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 14, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 200615 OR 200422. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. POTENTIAL: 31MAY2022 OR 31MAR2022. POTENTIAL: 04987350773630 OR 04987350773630. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. POTENTIAL: 15JUN2020 OR 22APR2020. THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. MECHANISM OF THE BREAK OF THE GUIDEWIRE: THE GUIDEWIRE MAY BE BROKEN OFF WHEN IT HAS BEEN SUBJECTED TO ONE OF THE FOLLOWING LOADS, AND THE BROKEN SECTION OF THE CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE LOAD THE GUIDEWIRE HAS BEEN SUBJECTED TO. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE: DIMPLE PATTERN IS OBSERVED ON THE BROKEN SURFACE OF THE CORE WIRE. NO TAPERED DEFORMATION IS OBSERVED ON THE BROKEN END. ONE-WAY CONTINUOUS TORQUE LOAD TO A BENT GUIDEWIRE: RADIAL STREAKS ARE OBSERVED ON THE BROKEN SURFACE OF THE CORE WIRE. PULLING LOAD IN ONE DIRECTION: THE BROKEN END OF THE CORE WIRE HAS BEEN TAPERED. PULLING LOAD TO A GUIDEWIRE KEPT IN A LOOP: THE BROKEN END OF THE CORE WIRE HAS BEEN CURVED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE POTENTIAL PRODUCT CODE/LOT# COMBINATIONS WERE CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S 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 GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. DO NOT APPLY REPETITIVE BENDING FORCE TO ONE SPECIFIC POINT OF THE DEVICE AS THIS MAY CAUSE DAMAGE TO THE GUIDE WIRE M. IT IS LIKELY THAT THE ACTUAL SAMPLE WAS BROKEN OFF DUE TO HAVING BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED ABOVE. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. PLEASE SEE MDR 2243441-2020-00067 FOR THE IMPORTER REPORT. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TIP OF THIS GLIDEWIRE BROKE OFF AFTER REPEATED USE WHERE TECHNIQUES OF LOOPING THE WIRE AND USING WITH A CATHETER WERE ATTEMPTED TO CROSS AN INNOMINATE VEIN OCCLUSION. THE TIP BROKE OFF APPROXIMATELY 1.5CM FROM THE DISTAL WIRE TIP. THE TIP WAS ATTEMPTED TO BE RETRIEVED; HOWEVER, WAS UNSUCCESSFUL. THE TIP MIGRATED TO A COLLATERAL VEIN WHERE THE PHYSICIAN DEEMED IT SAFE TO LEAVE AND MORE DAMAGE MAY HAVE BEEN CAUSED ATTEMPTING TO RETRIEVE. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 30NOV2020. THE PROCEDURE WAS AN INNOMINATE VEIN RECANALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471078 RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF*PA35183A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other