BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 21098850 · Received January 7, 2025

    Report

    Report Number
    9681834-2024-00253
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    December 4, 2024
    Report Date
    January 7, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 510(K): K122590, K163004. THE ACTUAL DEVICE HAS NOT BEEN RETURNED; THEREFORE, THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT NUMBER. - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO SIMILAR EVENT WAS FOUND IN THE PAST COMPLAINT FILE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE ONLY ITEM RETURNED WAS THE RADIFOCUS GLIDEWIRE ADVANTAGE (HEREINAFTER REFERRED TO AS ADVANTAGE), AND NO NAVICROSS WAS RETURNED.. 1. VISUAL INSPECTION (UNAIDED EYE AND DIGITAL MICROSCOPE) - NO FRACTURE OR SIMILAR ANOMALY WAS FOUND AT THE DISTAL END. - A LINEAR DENT AND AN ELONGATION OF OUTER LAYER TOWARD THE DISTAL END WERE OBSERVED IN THE AREA APPROXIMATELY 18 MM FROM THE DISTAL END. - NO OTHER APPEARANCE ANOMALIES WERE FOUND IN OTHER PARTS OF THE ACTUAL SAMPLE. 2. VISUAL INSPECTION (X-RAY FLUOROSCOPE) THERE WAS NO ANOMALY IN THE GOLD COIL IN THE DISTAL SECTION. 3. DIMENSIONS THE OUTER DIAMETER OF THE HYDROPHILIC-COATED AND THE PTFE-COATED SECTIONS MET THE FACTORY'S CONTROL STANDARDS, AND NO ANOMALIES WERE OBSERVED. 4. COMBINATION TEST AN ATTEMPT TO COMBINE THE ACTUAL SAMPLE WITH A FACTORY-RETAINED NAVICROSS WAS MADE. IT WAS CONFIRMED THAT THE INSERTION WAS POSSIBLE WITH NO RESISTANCE. 5. PROVIDED PHOTO OF THE ACTUAL SAMPLE IT SHOWED THAT THERE WAS A LINEAR FOREIGN SUBSTANCE AT THE DISTAL END OF THE ACTUAL SAMPLE. HOWEVER, THE FOREIGN SUBSTANCE WAS NOT RETURNED, THEREFORE THE INVESTIGATION OF IT WAS IMPOSSIBLE. 6. CAUSE OF OCCURRENCE/CONCLUSION THE INVESTIGATION RESULTS REVEALED THAT THERE WERE NO ABNORMALITIES IN THE MANUFACTURING HISTORY RECORDS OR THE DIMENSIONS OF THE ACTUAL SAMPLE. ADDITIONALLY, THE REPORTED CONDITION OF THE ACTUAL SAMPLE, AS DESCRIBED IN THE PPR ("THE DISTAL TIP WAS COMPLETELY DESTROYED"), WAS NOT CONFIRMED. FURTHERMORE, IT WAS CONFIRMED THAT THE ACTUAL SAMPLE COULD BE COMBINED WITH A FACTORY-RETAINED NAVICROSS, AND THE REPORTED EVENT WAS NOT REPLICATED IN THE ACTUAL SAMPLE. IT IS UNLIKELY THAT THE LINEAR FOREIGN SUBSTANCE SHOWN IN THE PROVIDED PHOTO ORIGINATED FROM THE ADVANTAGE. HOWEVER, SINCE THE LINEAR FOREIGN SUBSTANCE WAS NOT RETURNED, A DETAILED INVESTIGATION COULD NOT BE CONDUCTED. IT IS ASSUMED THAT THE LINEAR FOREIGN SUBSTANCE WAS WRAPPED AROUND THE ACTUAL SAMPLE AND SUBSEQUENTLY EXPERIENCED A PULLING FORCE, RESULTING IN THE FORMATION OF A LINEAR DENT AND ELONGATION OF THE OUTER LAYER. HOWEVER, DUE TO THE ABSENCE OF THE RETURNED FOREIGN SUBSTANCE AND LACK OF DETAILED INFORMATION REGARDING THE PROCEDURE, IT IS NOT POSSIBLE TO IDENTIFY THE LINEAR FOREIGN SUBSTANCE AND THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: - IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIREADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIREADVANTAGE 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. - CAREFULLY HANDLE THE PRODUCT UNDER FLUOROSCOPY. IF ANY RESISTANCE IS FELT WHILE HANDING THE PRODUCT, IMMEDIATELY STOP THE MANIPULATION AND FIND OUT CAUSE OF THE RESISTANCE IN ORDER TO AVOID DAMAGE TO BLOOD VESSELS AND SEPARATION OR BREAKAGE OF THE PRODUCT. - BEFORE INSERTING/WITHDRAWING THE PRODUCT, CLEAN THE SURFACE OF THE GUIDE WIRE WITH GAUZE MOISTENED WITH SALINE SOLUTION. ADVANCING/WITHDRAWING THE PRODUCT OVER A GUIDE WIRE WITH RESIDUAL BLOOD ON ITS SURFACE OR A GUIDE WIRE WHICH IS NOT FULLY WET MAY RESULT IN SEPARATION OR BREAKAGE OF THE PRODUCT. (B)(4) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GUIDE HAS DISASSOCIATED HIMSELF. TIP DID NOT STAY ON (MICRODISSECTION). THE SURGEON USED THE GWA018 GUIDE IN A NAVICROSS 018 WITHOUT PARTICULARLY FORCING IT, AND HAD TO REMOVE THE GUIDE, BECAUSE FROM THE FIRST GESTURE, THE DISTAL TIP WAS COMPLETELY DESTROYED. THE GUIDE "STRIPPED" DURING USE WHILE IN THE PATIENT. IT WAS USED WITH A SUPPORT CATHETER NAVICROSS 0.018 . A PORTION OF THE GUIDE REMAINED STUCK IN THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. CLINICAL CONSEQUENCES: NO RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011547 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM 240621A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O NAVICROSS SUPPORT CATHETER 0.018.