BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER

    MDR report key: 10194690 · Received June 25, 2020

    Report

    Report Number
    9681834-2020-00124
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 25, 2020
    Report Date
    June 25, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE ADDITIONAL INFORMATION IN SECTION B5.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2020. THE DOCTOR CONCLUDED THAT THERE WAS NO CAUSAL LINK BETWEEN THE ACTUAL SAMPLE AND RETROPERITONEAL HEMATOMA. UNDERLYING PATHOLOGY AND SPECIFIC OPERATION METHOD: CATHETER ABLATION FOR ATRIAL FIBRILLATION. CAUSAL RELATIONSHIP BETWEEN THE ACTUAL SAMPLE AND RETROPERITONEAL HEMATOMA: NONE. NO ABERRANT INSERTION OCCURRED, AND THE PATIENT WAS WITH STABLE POST-OPERATION OUTCOME. THE PATIENT VISITED THE FACILITY TWO DAYS AFTER DISCHARGED COMPLAINING ABOUT LOWER-BACK PAIN, (THE PATIENT USUALLY SUFFERS LOWER-BACK PAIN), AND THEN RETROPERITONEAL HEMATOMA WAS FOUND BY A CT. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS AND WAS DISCHARGED AFTER RECUPERATED THROUGH REHABILITATION. DOCTOR'S COMMENT: CONSIDERING THAT IT WAS A COMMON PROCEDURE, NO VASCULAR DAMAGE OCCURRED DUE TO THE ACTUAL SAMPLE, AND THE HEMATOMA OCCURRED A COUPLE OF DAYS AFTER THE OPERATION, THE HEMATOMA WAS LIKELY TO BE IDIOPATHIC AND NOT ATTRIBUTABLE TO THE ACTUAL SAMPLE. IN ADDITION, THE PATIENT IS TAKING MEDICATIONS THAT MAY CONTRIBUTE TO THE GENERATION OF HEMATOMA.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510K: 510(K): K062858, K082644. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD OR THE SHIPPING INSPECTION RECORD. FROM THE INVESTIGATION, A CAUSAL LINK BETWEEN THE USE OF RADIFOCUS INTRODUCER II H AND ADVERSE EFFECT TO THE HUMAN BODY COULD NOT BE CLARIFIED. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THIS REPORT IS FOR THE SECOND EVENT REPORTED, FOR THE FIRST EVENT REPORTED WITH THE SAME DEVICE THAT WAS USED ON THE SAME PATIENT SEE MDR 9681834-2020-00123. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER WAS USED DURING THE PROCEDURE. A RETROPERITONEAL HEMATOMA OCCURRED. THE PATIENT WAS HOSPITALIZED DUE TO PAIN IN THE RIGHT GROIN. A CONTRAST CT WAS ASSESSED, AND DIAGNOSIS OF RETROPERITONEAL HEMATOMA WAS MADE. THE SIZE OF THE HEMATOMA DECREASED EACH DAY AND REHABILITATION WAS INTRODUCED THE LAST SEVEN DAYS. THE PATIENT WAS DISCHARGED. THE PHYSICIAN CONFIRMED THAT THEY DO NOT ATTRIBUTE THE HEMATOMA TO THE CATHETER OR THE INTRODUCER. IT WAS INDICATED THE CAUSE MAY HAVE BEEN THE ANTICOAGULATION OR THE PUNCTURE NEEDLE/GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659311 RADIFOCUS INTRODUCER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1