BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 14651820 · Received June 10, 2022

    Report

    Report Number
    2029046-2022-01253
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    April 30, 2021
    Report Date
    June 9, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN S, CHUN KRJ, BORDIGNON S, TOHOKU S, SCHMIDT B. EPICARDIAL MAPPING AND ABLATION FOR VENTRICULAR ARRHYTHMIAS IN EXPERIENCED CENTER WITHOUT ONSITE CARDIAC SURGERY. GLOB CARDIOL SCI PRACT. 2021 APR 30;2021(1):E202103. DOI: 10.21542/GCSP.2021.3. PMID: 34036089; PMCID: PMC8133788. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN S, CHUN KRJ, BORDIGNON S, TOHOKU S, SCHMIDT B. EPICARDIAL MAPPING AND ABLATION FOR VENTRICULAR ARRHYTHMIAS IN EXPERIENCED CENTER WITHOUT ONSITE CARDIAC SURGERY. GLOB CARDIOL SCI PRACT. 2021 APR 30;2021(1):E202103. DOI: 10.21542/GCSP.2021.3. PMID: 34036089; PMCID: PMC8133788. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE: EPICARDIAL ACCESS IS SOMETIMES REQUIRED TO EFFECTIVELY TREAT VENTRICULAR ARRHYTHMIAS, BUT IT CAN BE ASSOCIATED WITH INCREASED RISK OF PROCEDURAL COMPLICATIONS NEEDING SURGICAL INTERVENTION. THE PRESENT STUDY AIMED TO EVALUATE THE FEASIBILITY AND SAFETY OF EPICARDIAL. MAPPING/ABLATION IN EXPERIENCED CENTER WITHOUT ONSITE CARDIAC SURGERY. METHODS: PATIENTS WHO HAD DRUG-REFRACTORY, RECURRENT VENTRICULAR ARRHYTHMIAS WERE SCHEDULED FOR CATHETER ABLATION. ALL OPERATORS (SC, JC, SB, BS) HAD AT LEAST FIFTY PERICARDIAL PUNCTURE EXPERIENCES. EPICARDIAL PUNCTURE AND PERIOPERATIVE ANTICOAGULATION WERE CARRIED OUT BASED ON INSTITUTIONAL PROTOCOL. PHRENIC NERVE WAS MAPPED BY 3-D MAPPING SYSTEM. CORONARY ANATOMY WAS DELINEATED BY CORONARY ANGIOGRAPHY. RESULTS: A TOTAL OF 44 PATIENTS (63.3 YEARS, MALE 86.4%) RECEIVED EPICARDIAL ACCESS. OF THEM 7 (15.9%) WERE SCHEDULED FOR PVC ABLATION, 37 (84.1%) FOR VT ABLATION (ICM: 25%, NICM: 59.1%). MEAN LVEF WAS 41.3%. ACUTE ABLATION SUCCESS RATE WAS 35 (79.5%). PROCEDURAL ADVERSE EVENTS INCLUDED: PERICARDIAL EFFUSION OCCURRED IN 3 (6.8%) PATIENTS WHO ALL WELL TREATED WITH PERICARDIAL DRAINAGE; AND PERICARDIAL TAMPONADE IN 1 (2.3%) PATIENT REQUIRING TRANSFER TO SURGICAL INTERVENTION. NO DEATH, STROKE, PHRENIC NERVES PALSY, OR CORONARY ARTERY INJURY WERE OBSERVED. MEDIAN HOSPITALIZATION WAS 4 (36) DAYS. UNIVARIABLE ANALYSIS AND ROC CURVE SHOWED THAT PATIENTS' AGE WAS A SIGNIFICANT PREDICTOR OF EPICARDIAL PROCEDURAL COMPLICATION (AREA UNDER CURVE (AUC): 0.813, P 0:041). CONCLUSIONS: GUIDED BY A TAILORED PROCEDURAL PROTOCOL, THE MAJORITY OF THE EPICARDIAL ACCESS RELATED COMPLICATIONS CAN BE TREATED CONSERVATIVELY WITHOUT NEEDING ONSITE SURGERY. OLDER AGE IS A RISK FACTOR ASSOCIATED WITH EPICARDIAL ACCESS RELATED COMPLICATIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL, SF/STSF, BIOSENSE WEBSTER. OTHER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO, BIOSENSE WEBSTER. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: 17 G-TUOHY NEEDLE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WERE A TOTAL OF 4 ADVERSE EVENTS REPORTED: THREE PATIENTS HAD PERICARDIAL EFFUSIONS WHICH WERE MANAGED BY EPICARDIAL DRAINAGE AND CONSERVATIVE TREATMENT. ONE PATIENT HAD PERICARDIAL TAMPONADE (ASPIRATED BLEEDING VOLUME 1000 ML, HEMOGLOBIN DROPPED FROM 16 G/DL TO 13 G/DL) ONE DAY AFTER THE PROCEDURE; WITHIN THE SAME DAY, THE PATIENT WAS TRANSFERRED TO SURGICAL CENTER DUE TO RECURRENT PERICARDIAL BLEEDING DESPITE OF INTERNAL TREATMENT. DURING THE THORACOTOMY SURGERY, FURTHER 300 ML PERICARDIAL BLEEDING WAS ASPIRATED, BLOOD CLOT WAS REMOVED, AND ONE EPICARDIAL BLEEDING SPOT WAS FOUND AND REPAIRED. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED TEN DAYS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599667 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R 17 G-TUOHY NEEDLE| UNK_CARTO 3