BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 19729158 · Received July 12, 2024

    Report

    Report Number
    9681834-2024-00115
    Event Type
    Death
    Date Received
    July 12, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 12, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF DEATH: UNKNOWN. D4: UDI: N/A AS 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: 510(K) NUMBER: K926214. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. ALTHOUGH THE LOT NUMBER WAS UNKNOWN, AN INVESTIGATION FOR "LOT: 230202YA" WAS PERFORMED. IT HAS BEEN INFORMED THAT THE INVOLVED PRODUCT WAS MOST LIKELY FROM THIS LOT. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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. 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 ON (B)(6) 2024, A PROCEDURE WAS PERFORMED TO IMPLANT A COMPETITOR'S STENT GRAFT FOR THE REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. TO REPAIR THE MIGRATION OF COMPETITOR'S STENT GRAFT, AN ADDITIONAL EXCLUDER Y-SHAPED STENT GRAFT SYSTEM (HEREINAFTER REFERRED TO AS "THIS PRODUCT") WAS PLACED. WHEN DEPLOYED, THIS PRODUCT MOVED TOWARD THE CENTER. THE LEFT RENAL ARTERY WAS COMPLETELY OCCLUDED, AND THE RIGHT RENAL ARTERY WAS PARTIALLY OCCLUDED. THE PATIENT HAD AN OPEN STENT PLACED IN THE THORACIC AORTA; THEREFORE, AN ATTEMPT WAS MADE TO RESTORE BLOOD FLOW FROM THE FEMORAL ARTERY TO THE RIGHT RENAL ARTERY. WHEN APPROACHING THE RENAL ARTERY, THE GUIDEWIRE (RADIFOCUS GUIDE WIRE M) COULD BE INSERTED SLIGHTLY; HOWEVER, IT WAS DIFFICULT WHEN ATTEMPTING TO ADVANCE IT DEEPER. UPON REPEATED MANIPULATIONS MULTIPLE TIMES, THE PATIENT'S BLOOD PRESSURE DECREASED, AND THE OCCURRENCE OF AORTIC DISSECTION WAS SUSPECTED. TWO ADDITIONAL STENT GRAFTS WERE PLACED OVERLAPPING THE OPEN STENT JUST ABOVE THE ABDOMINAL AORTA. THE PATIENT'S CONDITION DID NOT IMPROVE. THE PATIENT THEN PASSED AWAY (THE EXACT DATE WAS UNKNOWN), NOT DUE TO A PRODUCT DEFECT. IT WAS UNKNOWN IF PART OF THE PRODUCT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316082 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A 230202YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D