BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 14640928 · Received June 9, 2022

    Report

    Report Number
    2029046-2022-01240
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    August 8, 2021
    Report Date
    June 8, 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: DARMA A, BERTAGNOLLI L, TORRI F, PAETSCH I, JAHNKE C, DINOV B, HINDRICKS G, ARYA A. LV PSEUDOANEURYSM WITH CONCOMITANT MITRAL VALVE DEFECT AFTER LV SUMMIT ABLATION: A RARE LATE COMPLICATION. JACC CASE REP. 2021 NOV 17;3(16):1756-1759. DOI: 10.1016/J.JACCAS.2021.08.008. PMID: 34825204; PMCID: PMC8603023. 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: DARMA A, BERTAGNOLLI L, TORRI F, PAETSCH I, JAHNKE C, DINOV B, HINDRICKS G, ARYA A. LV PSEUDOANEURYSM WITH CONCOMITANT MITRAL VALVE DEFECT AFTER LV SUMMIT ABLATION: A RARE LATE COMPLICATION. JACC CASE REP. 2021 NOV 17;3(16):1756-1759. DOI: 10.1016/J.JACCAS.2021.08.008. PMID: 34825204; PMCID: PMC8603023. OBJECTIVE/METHODS/STUDY DATA: A (B)(6)-YEAR-OLD MALE PATIENT WITH HIGHLY SYMPTOMATIC, MONOMORPHIC, PREMATURE VENTRICULAR CONTRACTIONS PRESENTED FOR REPEAT ABLATION AFTER FAILED ENDOCARDIAL ABLATION. THREE WEEKS AFTER EXCESSIVE ENDOCARDIAL AND EPICARDIAL ABLATION ON THE LEFT VENTRICULAR SUMMIT, THE PATIENT WAS ADMITTED AGAIN WITH TAMPONADE FOLLOWING A PSEUDOANEURYSM ON THE ABLATION SITE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL, BIOSENSE-WEBSTER, OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO- 3 SYSTEM. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILIS TRANSSEPTAL NEEDLE, ST. JUDE MEDICAL. AGILIS EPI, ABBOTT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THE PATIENT SUFFERED CARDIAC TAMPONADE AND PSEUDOANEURYSM OF THE LATERAL ANTEROBASAL WALL OF THE LEFT VENTRICLE. THE PATIENT UNDERWENT EMERGENCY PERICARDIOCENTESIS, WHERE 500 ML HEMORRHAGIC PERICARDIAL EFFUSION WAS DRAINED, AND INJURY OF THE CORONARY ARTERIES WAS EXCLUDED. GIVEN THESE FINDINGS, PERFORATION OF THE PSEUDOANEURYSM WAS SUSPECTED, AND THE PATIENT WAS REFERRED TO THE SURGICAL DEPARTMENT FOR EMERGENCY OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632074 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R AGILIS EPI, ABBOTT| AGILIS TRANSSEPTAL NEEDLE, ST. JUDE MEDICAL| CARTO 3 SYSTEM