BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 8435635 · Received March 20, 2019

    Report

    Report Number
    9681834-2019-00034
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 20, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K122590 AND K163004 H6: PATIENT CODE: 3191: DEVICE COMPONENT WAS IN THE PATIENT, HOWEVER, WAS ABLE TO BE REMOVED. H6 - RESULTS - 3252 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; 213 IS BASED UPON EVALUATION OF THE UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. H6 - CONCLUSION - 4310 IS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; 67 IS BASED UPON EVALUATION OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND THE ACTUAL SAMPLE HAD A CRACKED DISTAL END. THE ACTUAL SAMPLE WAS FOUND TO BE APPROXIMATELY 2970MM IN TOTAL LENGTH. SPECIFIED TOTAL LENGTH OF THIS PRODUCT CODE IS APPROXIMATELY 3000MM. THE ACTUAL SAMPLE WAS FOUND TO BE MISSING A DISTAL SEGMENT APPROXIMATELY 30MM IN LENGTH. MAGNIFYING INSPECTIONS OF THE CRACKED END REVEALED THAT THE URETHANE OUTER LAYER HAD A CONFIGURATION IMPLYING THAT IT HAD BEEN RIPPED OFF. SOME CREASES HAD BEEN GENERATED ON THE URETHANE OUTER LAYER. THE URETHANE OUTER LAYER HAD BEEN STRETCHED APPROXIMATELY 1.7MM IN LENGTH. THE URETHANE OUTER LAYER AROUND THE CRACKED DISTAL END WAS DISSOLVED AND REMOVED. THE EXPOSED CRACKED DISTAL END OF THE CORE WIRE WAS INSPECTED UNDER ELECTRON MICROSCOPE AND REVEALED THE CRACKED DISTAL END HAD BEEN FLEXED. THE SURFACE OF THE CRACKED CROSS-SECTION WAS IN THE ROUGH STATE. THE REMAINDERS OF THE ACTUAL SAMPLE WERE INSPECTED UNDER MAGNIFICATION AND CONFIRMED TO HAVE NO ANOMALY. THE OUTSIDE DIAMETER OF THE URETHANE OUTER LAYER WAS MEASURED ON THE UNDAMAGED SEGMENT AND FOUND TO MEET THE MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED. A PRODUCT SAMPLE WAS SUBJECTED TO A PULLING FORCE IN THE STATE OF BEING FORMED INTO A LOOP-LIKE SHAPE TILL IT GOT FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE CORE WIRE HAD BEEN FLEXED TOWARD THE FRACTURE END WITH THE SURFACE OF THE FRACTURE CROSS-SECTION BEING IN THE ROUGH STATE. THIS STATE WAS FOUND TO BE VERY SIMILAR TO THAT SEEN ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE BENDING FORCES AT A 90-DEGREE ANGLE TILL IT GOT FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THAT THE FRACTURE CROSS SECTION HAD A DIMPLE PATTERN WITH NO DIMINISHMENT OF THE OUTSIDE DIAMETER TOWARD THE FRACTURE END. THIS STATE DIFFERS FROM THAT SEEN ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE ONE-WAY TORQUE FORCE IN THE CURVED STATE TILL IT GOT FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE GENERATION OF A RADIAL PATTERN ON THE FRACTURE CROSS-SECTION SURFACE. THIS STATE DIFFERS FROM THAT SEEN ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE WAS SUBJECTED TO A ONE-WAY PULLING FORCE TILL IT GOT FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE REVEALED THE OUTSIDE DIAMETER OF THE WIRE HAD BEEN DIMINISHED TOWARD THE FRACTURE END. THIS STATE DIFFERS FROM THAT SEEN ON THE ACTUAL SAMPLE A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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 DISTAL SECTION OF THE ACTUAL SAMPLE WAS TRAPPED DUE TO SOME FACTOR(S). IN THAT STATE THE ACTUAL SAMPLE WAS PUSHED FORWARD AND THIS CAUSED THE DISTAL SEGMENT TO GET BENT. SUBSEQUENT ROTATING MANIPULATION LED THE BENT SECTION TO FORM INTO A LOOP SHAPE. IN THAT STATE THE ACTUAL SAMPLE WAS SUBJECTED TO A PULLING FORCE, RESULTING IN THE FRACTURE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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. DO NOT APPLY REPETITIVE BENDING FORCE TO ONE SPECIFIC POINT OF THE DEVICE AS THIS MAY CAUSE DAMAGE TO THE GLIDEWIRE ADVATAGE." 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 THAT WHEN THE DOCTOR MADE A LOOP WITH THE RADIFOCUS GLIDEWIRE ADVANTAGE THE WIRE CRACKED AND THE TIP BROKE OFF. THE DOCTOR WAS ABLE TO RESCUE THE END OF THE WIRE. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229083 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention