BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 8202230 · Received December 28, 2018

    Report

    Report Number
    9681834-2018-00232
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    November 30, 2018
    Report Date
    December 28, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE POTENTIAL LOT NUMBERS AND EXPIRATION DATES FOR THE REPORTED INVOLVED PRODUCT AND TO PROVIDE THE DEVICE HISTORY RECORD REVIEW. THE FOLLOWING POTENTIAL LOT NUMBER/EXPIRATION COMBINATIONS WERE PROVIDED FOR THE INVOLVED PRODUCT. 1) 180713/200630, 2) 180911/200831, 3) 180803/200731. A REVIEW OF THE REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K122590 AND K163004 RESULTS - 3211 IS BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 213 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. H6 - CONCLUSION - 4310 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; 67 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN DEFORMED ON 0 - APPROXIMATELY 2MM FROM THE DISTAL END OF THE DEVICE. THERE WAS A KINK ON APPROXIMATELY 20MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE DEFORMED URETHANE OUTER LAYER REVEALED THE FOLLOWING. THE GOLD COIL HAD BEEN STRETCHED AND EXPOSED AT THE DISTAL END OF THE DEVICE. THE INTERMEDIATE SECTION HAD BEEN STRETCHED AND WHITENED. THE EDGES HAD BEEN COMPRESSED. SOME PARTS OF THE URETHANE OUTER LAYER HAD BEEN TORN. SOME CREASES AND ABRASIONS HAD BEEN GENERATED. THE DEFORMATION OF THE URETHANE OUTER LAYER AND ELONGATION OF THE GOLD COIL MADE IT IMPOSSIBLE TO CHECK FOR ANY POSSIBLE ABSENCE OF THE GOLD COIL AND/OR THE OUTER URETHANE LAYER. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE KINKED SECTION REVEALED THAT THE OUTER SURFACE HAD BECOME ROUGH. THE URETHANE OUTER LAYER WAS DISSOLVED AND REMOVED FOR FURTHER INSPECTION OF THE DISTAL EXTREMITY OF THE CORE WIRE. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL EXTREMITY OF THE CORE WIRE FOUND THAT THE SURFACE OF THE CUT CROSS-SECTION HAD THE EVIDENCE THAT THE CORE WIRE HAD BEEN CUT AND PROCESSED WITH THE DEDICATED MACHINE ON THE PRODUCTION FLOOR. THIS VERIFIED THAT THERE WAS NO MISSING PORTION ON THE CORE WIRE. THE OUTER DIAMETER WAS MEASURED ON THE UNDAMAGED SECTION AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THE BENDING RESISTANCE OF THE SHAFT WAS DETERMINED ON THE UNDAMAGED SECTION AND VERIFIED TO MEET MANUFACTURER SPECIFICATIONS. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS MANIPULATED IN THE STATE OF ITS DISTAL SECTION BEING TRAPPED, RESULTING IN THE DEFORMATION ON THE URETHANE OUTER LAYER AND ELONGATION ON THE GOLD COIL. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. AS A CAUSE OF THE GENERATION OF THE KINK ON THE DISTAL SECTION, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO SOME EXTERNAL FORCE, INCLUDING BENDING FORCE AND ABRADING FORCE, WHICH EXCEEDED THE STRENGTH LIMIT OF THIS PRODUCT CODE. HOWEVER, IT IS DIFFICULT TO DETERMINE WHEN AND HOW THE ACTUAL SAMPLE WAS SUBJECTED TO THE EXTERNAL FORCE. IFU STATES: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR 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." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED SEPARATION OF THE URETHANE LAYER ON THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE DEVICE. RECANALIZATION OF THE SFA AND THE POLITEAL A. THE VESSEL WAS HIGHLY CALCIFIED WITH OCCLUSION WITH USE OF THE GWA18/300 IN COMBINATION WITH A NAVICROSS 0.35". WHEN THEY TRIED TO PASS THE LESION, THE COATING OF THE WIRE PEELED OFF, BUT IT DID NOT BECOME LOOSE FROM THE WIRE, SO THE NITINOL WAS VISIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041388 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1