BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION

    MDR report key: 20747642 · Received November 21, 2024

    Report

    Report Number
    2124215-2024-73342
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    September 15, 2023
    Report Date
    November 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    UDI-DI
    08714729841968
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # K143481, K192360, K220796. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED CEREBRAL EMBOLIC EVENTS WITH COMPLETE CLINICAL RECOVERY. PER LITERATURE REVIEW, IT WAS REPORTED THAT: IN THIS SINGLE-CENTER STUDY AT UNIVERSITY HOSPITAL DUSSELDORF, GERMANY, 380 PATIENTS UNDERGOING HIGH-DENSITY-MAPPING-GUIDED CATHETER ABLATION FOR CONSECUTIVE ATRIAL TACHYCARDIA OVER AN ENROLLMENT PERIOD OF 4 YEARS AFTER PREVIOUS ATRIAL FIBRILLATION CATHETER OR SURGICAL ABLATION WERE ANALYZED. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA OR DEEP SEDATION. THE CATHETERS CONSISTED OF AN EXPANDABLE, OPEN-IRRIGATED 64-ELECTRODE MINIBASKET INTELLAMAP ORION CATHETER AND AN OPEN-IRRIGATED 3.5-MM TIP MAPPING AND ABLATION CATHETER INTELLANAV MIFI OI CATHETER. THE LEFT ATRIUM WAS ACCESSED BY A TRANSSEPTAL PUNCTURE USING A FIXED CURVE SL0 LONG SHEATH FOR THE ABLATION CATHETER AND A ZURPAZ LONG STEERABLE SHEATH. A STEERABLE 6-F DECAPOLAR DIAGNOSTIC DYNAMIC CATHETER WAS PLACED IN THE CORONARY SINUS SERVING AS A REFERENCE. DURING ABLATION, RADIOFREQUENCY CURRENT WAS APPLIED USING A STANDARD POWER OF 30 W WITH ADJUSTMENTS OF 40 W AT THE CAVOTRICUSPID ISTHMUS AND 25 W AT THE LEFT ATRIAL POSTERIOR WALL, AND A PEAK TIP TEMPERATURE OF 42C. FOR MACRO-REENTRANT TACHYCARDIA, THE CRITICAL ISTHMUS SHOWING FRACTIONATED, LOW-AMPLITUDE SIGNALS WAS TARGETED IN ORDER TO TRANSECT THE CIRCUIT BY LINEAR ABLATION. LOCALIZED REENTRANT AND FOCAL TACHYCARDIAS WERE TARGETED BY ABLATION OF THE EARLIEST ACTIVATION. OF THE 380 PATIENTS THAT RECEIVED TREATMENT, 31 PRESENTED DIVERSE PATIENT COMPLICATIONS; 18 GROIN COMPLICATIONS, 7 PERICARDIAL EFFUSIONS, 2 CEREBRAL EMBOLIC EVENTS WITH COMPLETE CLINICAL RECOVERY, 1 ATRIOVENTRICULAR BLOCK I, 1 ATRIOVENTRICULAR BLOCK II, 1 MYOCARDIAL INFARCTION (WITH NO ST ELEVATION) AND 1 ACUTE-ON-CHRONIC KIDNEY DISEASE. DURING FOLLOW UP, PATIENTS UNDERWENT REPEAT PROCEDURES DUE TO ARRHYTHMIA RECURRENCES. NO PATIENTS SUFFERED MAJOR COMPLICATIONS (BLEEDING REQUIRING THORACOTOMY OR TRANSFUSION, PERMANENT PHRENIC NERVE PARALYSIS, PACEMAKER DEVICE IMPLANTATION, STROKE/TRANSIENT ISCHEMIC ATTACK, ATRIO-ESOPHAGEAL FISTULATE REQUIRING SURGERY, DEATH) DURING OR AFTER THE ABLATION. KAHLE, A.-K., ALKEN, F.-A., SCHERSCHEL, K., MEYER, C. (2023). PROGNOSTIC IMPLICATIONS OF BASELINE RHYTHM DURING CATHETER ABLATION FOR ATRIAL TACHYCARDIA. CLINICAL RESEARCH IN CARDIOLOGY. HTTPS://DOI.ORG/10.1007/S00392-023-02292-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999927 INTELLAMAP ORION CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC CORPORATION M004RC64S0 08714729841968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other