BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 20762078 · Received November 22, 2024

    Report

    Report Number
    9681834-2024-00214
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 22, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED . A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED . D4: UDI: N/A AT THIS PRODUCT CODE IS NOTE EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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. MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE: NO ANOMALY WAS FOUND IN THEM. PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE AND LOT NUMBER: NO OTHER SIMILAR ISSUE HAS BEEN REPORTED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    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. 1. VISUAL INSPECTION OF THE ACTUAL SAMPLE (UNAIDED EYE AND DIGITAL MICROSCOPE) THE OUTER LAYER AT THE DISTAL END HAD BEEN TORN OFF. THE DAMAGE TO THE OUTER LAYER RANGED APPROXIMATELY 0.6 MM FROM THE DISTAL END. THE CORE WIRE AND THE GOLD COIL WERE EXPOSED. NO APPEARANCE ANOMALY WAS FOUND IN THE OTHER PARTS. 2. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE THE DISTAL END OF THE CORE WIRE HAD A FIXED-SIZE CUT MARK (MARK THAT OCCURS WHEN CUTTING CORE WIRE DURING MANUFACTURE) SIMILAR TO THAT A CURRENT NORMAL PRODUCT HAD. FROM THIS, IT WAS LIKELY THAT THERE WAS NO PORTION MISSING FROM THE CORE WIRE. EVALUATION OF THE FRACTURED AREA OF THE OUTER LAYER FOUND IT WAS IN A PULLED-AND-TORN SHAPE, WITH A DENT AND CREASES OBSERVED ON THE SURFACE. 3. DIMENSIONS: THE OUTER DIAMETER OF THE HYDROPHILIC COAT AND THE PTFE-COAT SECTIONS MET THE FACTORY'S CONTROL STANDARDS, AND NO ANOMALIES WERE OBSERVED. 4. SIMULATION TEST: [TEST METHOD]: AN ATTEMPT WAS MADE TO REMOVE A GUIDEWIRE FROM A HOLDER TUBE BY GRASPING THE DISTAL END WITH FINGERTIPS AND APPLYING A MOMENTARY PULLING FORCE. [TEST RESULT]. THE OUTER LAYER WAS FRACTURED. THE CORE WIRE AND THE GOLD COIL WERE EXPOSED. THE FRACTURED AREA OF THE OUTER LAYER WAS IN A PULLED-AND-TORN SHAPE, WITH A DENT AND CREASES ON THE SURFACE THE CONDITION OF THE TESTED SAMPLE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. 5. CAUSE OF OCCURRENCE: THE INVESTIGATION RESULTS REVEALED NO ANOMALY IN THE MANUFACTURING RECORD OR IN THE DIMENSIONS OF THE ACTUAL SAMPLE. REGARDING THIS CASE, AS ONE POSSIBILITY, IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS LIKELY TO BE EXPOSED TO INSTANTANEOUS PULLING FORCE WHILE ITS DISTAL END WAS IN A TRAPPED STATE, SUCH AS PINCHED WITH FINGERS, WHICH RESULTED IN THE FRACTURED OUTER LAYER. HOWEVER, SINCE THE DETAILS OF THE PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY WHEN THE ACTUAL SAMPLE WAS TRAPPED AND EXPOSED TO SUCH PULLING FORCE. NOTE THAT, IF A PRODUCT EXHIBITS CONDITIONS SIMILAR TO THOSE OF THE ACTUAL SAMPLE DURING MANUFACTURING, IT CAN BE DETECTED WHEN IT IS INSERTED INTO THE HOLDER TUBE AND DURING THE VISUAL INSPECTION PRIOR TO PACKAGING. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GUIDEWIRE COATING PEELED OFF. GUIDE STRIPPED AT THE END, NOTICED UPON OPENING THE PACKAGING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798068 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18181CM 240419A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown