BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 20140523 · Received September 4, 2024

    Report

    Report Number
    3008452825-2024-00507
    Event Type
    Injury
    Date Received
    September 4, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC TAMPONADE COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, PAGES:1-12, 7/27/2024, IN AN ARTICLE TITLED "SELECTIVE COMPLEX FRACTIONATED ATRIAL ELECTROGRAM ABLATION BASED ON THE NUMBER-OF-FRACTIONATION FOR PERSISTENT ATRIAL FIBRILLATION REFRACTORY TO PULMONARY VEIN ISOLATION"; MASAHIRO MIZOBUCHI; HTTPS://DOI.ORG/10.1007/S10840-024-01889-6. A TOTAL OF 73 PEAF PATIENTS WITH RESIDUAL INDUCIBILITY OR FAILED CARDIOVERSIONS OF AF AFTER PVI WERE ENROLLED AND UNDERWENT NUMBER-OF-FRACTIONATION MAPPING (NFM) BY COUNTING THE NUMBER OF FRACTIONATIONS IN 2.5 S AT EACH OF THE POINTS USING THE CARTO3 (ICL MODE) AND ENSITE (FRACTIONATION MAP) SYSTEMS. AFTER NFM, SELECTIVE CFAE ABLATION (NFM-CA) TARGETING THE SITES OF THE UPPER 40% OF THE COUNTED FRACTION NUMBER (NF40) WAS PERFORMED AS AN ADDITIONAL PROCEDURE FOR REFRACTORY PEAF. WE INVESTIGATED THE PROGNOSIS OF THESE PATIENTS WITHIN 24 MONTHS AFTER THE INDEX ABLATION PROCEDURE AND THE RELATIONSHIP BETWEEN CHANGES IN ACTIVATION PATTERNS DURING THE ABLATION PROCEDURE AND THEIR PROGNOSIS. WE ALSO PERFORMED A PROPENSITY SCORE¿MATCHED ANALYSIS COMPARING THESE PATIENTS WITH HISTORICAL CONTROLS (HC) TO IDENTIFY THE OPTIMAL INDICATIONS FOR NFM-CA A CARDIAC TAMPONADE WAS NOTED IN A PATIENT OF THE NFM-CA (1.3%) AND IN TWO PATIENTS OF THE HC (1.3%). IT IS ALLEGED BY THE PHYSICIAN THAT THE TAMPONADES WERE DUE TO THE ABLATION CATHETER BEING PRESSED TOO HARD ON THE ROOF, HOWEVER, IT IS UNKNOWN WHAT CAUSED THE TAMPONADES. IT IS UNKNOWN WHAT ABLATION CATHETERS WERE USED DURING THE PROCEDURES. THE TAMPONADES ONLY REQUIRED MONITORING WITH NO INTERVENTION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, PAGES:1-12, 7/27/2024, IN AN ARTICLE TITLED "SELECTIVE COMPLEX FRACTIONATED ATRIAL ELECTROGRAM ABLATION BASED ON THE NUMBER-OF-FRACTIONATION FOR PERSISTENT ATRIAL FIBRILLATION REFRACTORY TO PULMONARY VEIN ISOLATION"; MASAHIRO MIZOBUCHI; HTTPS://DOI.ORG/10.1007/S10840-024-01889-6. A TOTAL OF 73 PEAF PATIENTS WITH RESIDUAL INDUCIBILITY OR FAILED CARDIOVERSIONS OF AF AFTER PVI WERE ENROLLED AND UNDERWENT NUMBER-OF-FRACTIONATION MAPPING (NFM) BY COUNTING THE NUMBER OF FRACTIONATIONS IN 2.5 S AT EACH OF THE POINTS USING THE CARTO3 (ICL MODE) AND ENSITE (FRACTIONATION MAP) SYSTEMS. AFTER NFM, SELECTIVE CFAE ABLATION (NFM-CA) TARGETING THE SITES OF THE UPPER 40% OF THE COUNTED FRACTION NUMBER (NF40) WAS PERFORMED AS AN ADDITIONAL PROCEDURE FOR REFRACTORY PEAF. WE INVESTIGATED THE PROGNOSIS OF THESE PATIENTS WITHIN 24 MONTHS AFTER THE INDEX ABLATION PROCEDURE AND THE RELATIONSHIP BETWEEN CHANGES IN ACTIVATION PATTERNS DURING THE ABLATION PROCEDURE AND THEIR PROGNOSIS. WE ALSO PERFORMED A PROPENSITY SCORE¿MATCHED ANALYSIS COMPARING THESE PATIENTS WITH HISTORICAL CONTROLS (HC) TO IDENTIFY THE OPTIMAL INDICATIONS FOR NFM-CA. A CARDIAC TAMPONADE WAS NOTED IN A PATIENT OF THE NFM-CA (1.3%) AND IN TWO PATIENTS OF THE HC (1.3%). IT IS ALLEGED BY THE PHYSICIAN THAT THE TAMPONADES WERE DUE TO THE ABLATION CATHETER BEING PRESSED TOO HARD ON THE ROOF, HOWEVER, IT IS UNKNOWN WHAT CAUSED THE TAMPONADES. IT IS UNKNOWN WHAT ABLATION CATHETERS WERE USED DURING THE PROCEDURES. THE TAMPONADES ONLY REQUIRED MONITORING WITH NO INTERVENTION. IT IS NOT ALLEGED THAT THE TAMPONADES WERE CAUSED BY ANY OF THE ABBOTT DEVICES USED DURING THE PROCEDURE. ONE PATIENT IN THE HC EXPERIENCED CARDIOGENIC STROKE 2 DAYS AFTER THE PROCEDURE AND RECOVERED BY THE EMERGENCY ENDOVASCULAR RETRIEVAL OF INTRACRANIAL THROMBUS. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT (CARTO) SYSTEM, AND THE CARDIOGENIC STROKE IS ALLEGED TO HAVE BEEN CAUSED DUE TO THE PATIENT NOT TAKING THEIR ANTICOAGULANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186331 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown