BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 18886950 · Received March 12, 2024

    Report

    Report Number
    9681834-2024-00041
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 3, 2024
    Report Date
    March 12, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. B3: DATE OF EVENT: REQUESTED, NOT PROVIDED. D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: PMA/510(K): K923607, K926214. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. THE RASH WAS SUBJECTED TO A BIOPSY IN THE INVOLVED HOSPITAL, AND STAINED IMAGES OF MID-LAYER OF DERMIS (LOW POWER) AND VESSELS OF THE SAME LAYER (HIGH POWER) WERE PROVIDED TO (B)(6). AN OBJECT THAT APPEARED TO BE A FOREIGN BODY WAS OBSERVED IN THE VESSEL, HOWEVER, IT COULD NOT BE DETERMINED FROM THE IMAGES WHETHER THE FOREIGN BODY WAS DERIVED FROM THE GUIDEWIRE. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT OF THE INVOLVED PRODUCT CODE/LOT NUMBER FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. FROM THE IMAGES PROVIDED BY THE FACILITY, IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE FOREIGN BODY IN QUESTION WAS DERIVED FROM THE ACTUAL PRODUCT. SINCE THE ACTUAL PRODUCT WAS NOT RETURNED AND ANALYSIS OF IT COULD NOT BE PERFORMED, THE CAUSE OF THE OCCURRENCE COULD NOT BE DETERMINED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "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." 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).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CASE WAS A RELAYPLUS IMPLANTATION POST-PROCEDURAL. ADDITIONAL IMPLANTATION OF RELAYPRO WAS PERFORMED ON (B)(6) 2024, THE LANDING ZONE AT THE PERIPHERAL SIDE HAD SHORTENED. APPROACHED FROM RIGHT FEMORAL ARTERY, GORE DRYSEAL 22FR WAS PLACED, AND IMPLANTATION OF RELAYPRO (B)(6) WAS ATTEMPTED THROUGH IT. AT FIRST, DELIVERY WAS ATTEMPTED WITH A LUNDERKIST DOUBLE STIFF WIRE, HOWEVER, IT WAS TEMPORARILY REMOVED IT COULD NOT REACH THE PLANNED LANDING ZONE (CENTRAL-SIDE END TO THE PROXIMAL PART OF ASCENDING AORTA AND THE PERIPHERAL-SIDE END TO THE CENTRAL PART OF THE ROOT OF CELIAC ARTERY). THE PROCEDURE WAS SWITCHED TO PULL-THROUGH TECHNIQUE AND A RADIFOCUS GUIDEWIRE (260 CM) WAS USED; HOWEVER, THE LENGTH WAS NOT LONG ENOUGH, AND THE ACTUAL SAMPLE (300 CM) WAS USED FOR THE DELIVERY TO THE DESIRED LOCATION. IT WAS REPLACED WITH A LUNDERKIST DOUBLE STIFF GUIDEWIRE AND IMPLANTATION TO THE PLANNED POSITION WAS COMPLETED. A TOUCH-UP WAS PERFORMED AT THE JOINT AREA. AN ANGIOGRAPHY SHOWED NO ENDOLEAK, AND THE PROCEDURE WAS FINISHED. AROUND TWO (2) DAYS AFTER THE PROCEDURE, A RASH WAS OBSERVED ON THE RIGHT THIGH AND LEFT THIGH. IT WAS EXTENSIVE IN THE RIGHT THIGH AND MILD IN THE LEFT THIGH. A BIOPSY OF THE RASH FOUND A FOREIGN BODY. IT WAS THOUGHT THAT THE RASH WAS CAUSED BY POOR BLOOD CIRCULATION DUE TO FOREIGN BODY SCATTERING INTO THE PERIPHERAL BLOOD VESSELS. NO TREATMENT WAS GIVEN FOR THE RASH. A FOLLOW-UP WAS PERFORMED, AND THE RASH HAS DISAPPEARED AS OF (B)(6) 2024. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT SERIOUSLY HARMED. THE RESIDUE IN THE PATIENT WAS NOT RETRIEVABLE. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909761 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 230720YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown RADIFOCUS GUIDEWIRE 0.035"| RELAYPRO STENT GRAFT| SHEATH INTRODUCER