BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER

    MDR report key: 10471628 · Received August 31, 2020

    Report

    Report Number
    2134265-2020-12025
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    March 1, 2017
    Report Date
    August 31, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    PMA / PMN Number
    K143481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICES, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AGE AT TIME OF EVENT: 64.27 YEARS (STANDARD DEVIATION 9.86) SEX: 22 MALES / 15 FEMALES.

    Description of Event or Problem · 1

    ROTTNER, LAURA ET AL. "DIRECT COMPARISON OF POINT-BY-POINT AND RAPID ULTRA-HIGH-RESOLUTION ELECTROANATOMICAL MAPPING IN PATIENTS SCHEDULED FOR ABLATION OF ATRIAL FIBRILLATION". JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, VOL 28, NO. 3, 2017, PP. 289-297. WILEY, DOI:10.1111/JCE. INTRODUCTION: THREE-DIMENSIONAL ELECTROANATOMICAL MAPPING (EAM) IS AN ESTABLISHED TOOL FACILITATING CATHETER ABLATION. IN THIS CONTEXT, THE NOVEL RHYTHMIA SYSTEM SETS A NEW BAR IN FAST HIGH-RESOLUTION MAPPING. THE AIM OF THIS STUDY WAS TO DIRECTLY COMPARE POINT-BY-POINT VERSUS RAPID ULTRA-HIGH-RESOLUTION EAM IN PATIENTS SCHEDULED FOR ABLATION OF ATRIAL FIBRILLATION (AF) WITH FOCUS ON PROCEDURAL DATA, ACUTE SUCCESS, AND MIDTERM CLINICAL OUTCOME. THE ARTICLE REPORTED THAT OF 37 PATIENTS, ONE PERICARDIAL TAMPONADE REQUIRING PERICARDIOCENTESIS OCCURRED AND WAS JUDGED AS "PROBABLY" UNRELATED TO THE BASKET CATHETER. IN ADDITION, ONE TRANSIENT AIR EMBOLISM OCCURRED IN THE RIGHT CORONARY ARTERY, RESOLVING SPONTANEOUSLY AFTER SIX MINUTES. ALL CATHETERS WERE CAREFULLY CHECKED AND FOUND TO BE FREE FROM ANY VISIBLE THROMBUS FORMATION AT THE END OF THE ABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938634 INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION 87035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention