BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_NAVISTAR RMT THERMOCOOL

    MDR report key: 14639332 · Received June 8, 2022

    Report

    Report Number
    2029046-2022-01231
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    December 20, 2021
    Report Date
    June 8, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DE OLIVEIRA DIETRICH C, DE OLIVEIRA HOLLANDA L, CIRENZA C, DE PAOLA AAV. EPICARDIAL AND ENDOCARDIAL ABLATION BASED ON CHANNEL MAPPING IN PATIENTS WITH VENTRICULAR TACHYCARDIA AND CHRONIC CHAGASIC CARDIOMYOPATHY: IMPORTANCE OF LATE POTENTIAL MAPPING DURING SINUS RHYTHM TO RECOGNIZE THE CRITICAL SUBSTRATE. J AM HEART ASSOC. 2022 JAN 4;11(1):E021889. DOI: 10.1161/JAHA.121.021889. EPUB 2021 DEC 20. PMID: 34927451; PMCID: PMC9075208. 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 THE 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: DE OLIVEIRA DIETRICH C, DE OLIVEIRA HOLLANDA L, CIRENZA C, DE PAOLA AAV. EPICARDIAL AND ENDOCARDIAL ABLATION BASED ON CHANNEL MAPPING IN PATIENTS WITH VENTRICULAR TACHYCARDIA AND CHRONIC CHAGASIC CARDIOMYOPATHY: IMPORTANCE OF LATE POTENTIAL MAPPING DURING SINUS RHYTHM TO RECOGNIZE THE CRITICAL SUBSTRATE. J AM HEART ASSOC. 2022 JAN 4;11(1):E021889. DOI: 10.1161/JAHA.121.021889. EPUB 2021 DEC 20. PMID: 34927451; PMCID: PMC9075208. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: VENTRICULAR TACHYCARDIA (VT) IN PATIENTS WITH CHRONIC CHAGASIC CARDIOMYOPATHY (CCC) IS ASSOCIATED WITH CONSID ERABLE MORBIDITY AND MORTALITY. CATHETER ABLATION OF VT IN PATIENTS WITH CCC IS VERY COMPLEX AND CHALLENGING. THE MAIN GOAL OF THIS WORK WAS TO ASSESS THE EFFICACY OF VT CATHETER ABLATION GUIDED BY LATE POTENTIALS (LPS) IN PATIENTS WITH CCC. METHODS AND RESULTS: SEVENTEEN CONSECUTIVE PATIENTS WITH REFRACTORY VT AND CCC WERE PROSPECTIVELY INCLUDED IN THE STUDY. COMBINED ENDO-EPICARDIAL VOLTAGE AND LATE ACTIVATION MAPPING WERE OBTAINED DURING BASELINE RHYTHM TO DEFINE SCARRED AND LP AREAS, RESPECTIVELY. THE END POINT OF THE ABLATION PROCEDURE WAS THE ELIMINATION OF ALL IDENTIFIED LPS. EPICARDIAL AND ENDOCARDIAL DENSE SCARS (<0.5 MV) WERE DETECTED IN 17/17 AND 15/17 PATIENTS, RESPECTIVELY. LPS WERE DETECTED IN THE EPICARDIAL SCARS OF 16/17 PATIENTS AND IN THE ENDOCARDIAL SCARS OF 14/15 PATIENTS. A TOTAL OF 63 VTS WERE INDUCED IN 17 PATIENTS; 22/63 (33%) WERE STABLE AND ENTRAINED, PRESENTING LPS RECORDED IN THE ISTHMUS SITES. THE END POINT OF ABLATION WAS ACHIEVED IN 15 OF 17 PATIENTS. ABLATION WAS NOT COMPLETED IN 2 PATIENTS BECAUSE OF CARDIAC TAMPONADE OR VICINITY OF THE PHRENIC NERVE AND CIRCUMFLEX ARTERY. THREE PATIENTS (2 WITH UNSUCCESSFUL ABLATION) HAD VT RECURRENCE DURING FOLLOW-UP (39 MONTHS). -CONCLUSIONS: ENDO-EPICARDIAL LP MAPPING ALLOWS US TO IDENTIFY THE PUTATIVE ISTHMUSES OF DIFFERENT VTS AND EFFECTIVELY PERFORM CATHETER ABLATION IN PATIENTS WITH CCC AND DRUG-REFRACTORY VTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: NAVISTAR, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA: 3.5 MM IRRIGATED TIP CATHETER NAVISTAR- THERMOCOOL OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO SYSTEM. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PATIENT HAD PERICARDIAL TAMPONADE REQUIRING INTERRUPTION OF THE PROCEDURE AND SURGICAL REPAIR DUE TO LACERATION OF THE POSTERIOR INTERVENTRICULAR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893506 UNK_NAVISTAR RMT THERMOCOOL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L CARTO SYSTEM