BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15376251 · Received September 8, 2022

    Report

    Report Number
    2029046-2022-02148
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    June 1, 2018
    Report Date
    September 7, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUANG WEIPENG, LIN RUI, ZHOU HAOYUE, CHEN YANGBO, QING HONGSHENG. LOW-RAY RADIOFREQUENCY ABLATION GUIDED BY CART03 THREE-DIMENSIONAL MAPPING SYSTEM CLINICAL STUDY OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. CHINA MODERN MEDICINE, JUNE 2018, VOL. 25, NO. 18. [LITERATURE IDENTIFICATION CODE] A [ARTICLE NUMBER] 1674-4721 (2018) 6 (C) -0038-04 NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUANG WEIPENG, LIN RUI, ZHOU HAOYUE, CHEN YANGBO, QING HONGSHENG. LOW-RAY RADIOFREQUENCY ABLATION GUIDED BY CART03 THREE-DIMENSIONAL MAPPING SYSTEM CLINICAL STUDY OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. CHINA MODERN MEDICINE, JUNE 2018, VOL. 25, NO. 18. [LITERATURE IDENTIFICATION CODE] A [ARTICLE NUMBER] 1674-4721 (2018) 6 (C) -0038-04 OBJECTIVE/METHODS/STUDY DATA: -TO DISCUSS THE FEASIBILITY, SAFETY AND ADVANTAGES OF CART03 THREE-DIMENSIONAL MAPPING SYSTEM IN GUIDING RADIOFREQUENCY ABLATION FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA UNDER LOW-DOSE RADIATION. -METHODS A TOTAL OF 65 PATIENTS WITH PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) TREATED IN OUR HOSPITAL FEBRUARY 2015 TO NOVEMBER 201 7 WERE SELECTED AS THE SUBJECT, AND RANDOMLY DIVIDED INTO 2D GROUP (29 CASES) AND 3D GROUP (36 CASES). THE 2D GROUP USED CONVENTIONAL X-RAY GUIDE ABLATION, AND THE 3D GROUP USED CART03 UNDER LOW-DOSE RADIATION GUIDE ABLATION. THE PSVT TYPE, OPERATION TIME, X-RAY EXPOSURE TIME, X-RAY FLUOROSCOPY TIME AND COMPLICATION RATES WERE COM ¿ PARED BETWEEN THE TWO GROUPS. RESULTS ALL PROCEDURES WERE ACUTELY SUCCESSFUL, BUT ONE PATIENT IN THE 2D GROUP WAS DEVELOPED TRANSIENT DEGREE 11I ATRIOVENTRICULAR BLOCK DURING ABLATION. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE TOTAL OPERATION TIME BETWEEN THE TWO GROUPS (P > 0.05). THE X-RAY EXPOSURE TIME IN 3D GROUP WAS SHORTER THAN 2D GROUP, AND X-RAY FLUOROSCOPY TIME IN 3D GROUP WAS LESS THAN 2D GROUP, THE DIFFERENCES WERE STATISTICALLY SIGNIFICANT (P < 0.05). -CONCLUSION RADIOFREQUENCY ABLATION OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA WITH THE HELP OF THE CARTO 3 THREE-DIMENSIONAL MAPPING SYSTEM UNDER RADIATION IS SAFE AND FEASIBLE, AND IS HELPFUL TO REDUCE THE RADIATION INJURY OF THE DOCTORS AND PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: -NAVIGATION STAR TEMPERATURE-CONTROLLED ABLATION CATHETER, THIS WILL BE CODED AS UNK_NAVISTAR OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: -CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: -SR0 LONG VASCULAR SHEATH ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: -ONE PATIENT DEVELOPED TRANSIENT THIRD DEGREE ATRIOVENTRICULAR CONDUCTION STAGNATION DURING SURGERY, WHICH LASTED FOR ABOUT 10 S AND THEN RECOVERED SPONTANEOUSLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325559 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO 3| SR0 LONG VASCULAR SHEATH