BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PENTARAY NAV

    MDR report key: 12580518 · Received October 5, 2021

    Report

    Report Number
    2029046-2021-01680
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    April 16, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CANO Ó, PÉREZ-ROSELLÓ V, AYALA HD, IZQUIERDO M, OSCA J, SANCHO-TELLO MJ, MARTÍNEZ-DOLZ L. INFLUENCE OF BASELINE INDUCIBILITY AND ACTIVATION MAPPING ON ABLATION OUTCOMES IN PATIENTS WITH STRUCTURAL HEART DISEASE AND VENTRICULAR TACHYCARDIA. J CARDIOVASC ELECTROPHYSIOL. 2021 MAY;32(5):1328-1336. DOI: 10.1111/JCE.15035. EPUB 2021 APR 16. PMID: 33834564. 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 · 1

    "THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CANO Ó, PÉREZ-ROSELLÓ V, AYALA HD, IZQUIERDO M, OSCA J, SANCHO-TELLO MJ, MARTÍNEZ-DOLZ L. INFLUENCE OF BASELINE INDUCIBILITY AND ACTIVATION MAPPING ON ABLATION OUTCOMES IN PATIENTS WITH STRUCTURAL HEART DISEASE AND VENTRICULAR TACHYCARDIA. J CARDIOVASC ELECTROPHYSIOL. 2021 MAY;32(5):1328-1336. DOI: 10.1111/JCE.15035. EPUB 2021 APR 16. PMID: 33834564. OBJECTIVE AND METHODS: STAND-ALONE SUBSTRATE ABLATION HAS BECOME A STANDARD VENTRICULAR TACHYCARDIA (VT) ABLATION STRATEGY. THE AUTHORS SOUGHT TO EVALUATE THE INFLUENCE OF BASELINE VT INDUCIBILITY AND ACTIVATION MAPPING ON ABLATION OUTCOMES IN PATIENTS WITH STRUCTURAL HEART DISEASE (SHD) UNDERGOING VT ABLATION. THE PURPOSE OF THIS SINGLE CENTER, OBSERVATIONAL AND RETROSPECTIVE STUDY INCLUDING 160 CONSECUTIVE PATIENTS WITH SHD AND DOCUMENTED VT UNDERGOING ABLATION BETWEEN MARCH 2011 AND SEPTEMBER 2019. BASELINE VT INDUCTION WAS ATTEMPTED BEFORE ABLATION IN ALL PATIENTS AND VT ACTIVATION MAPPING PERFORMED WHEN POSSIBLE. ABLATION WAS GUIDED BY ACTIVATION MAPPING FOR MAPPABLE VTS PLUS SUBSTRATE ABLATION FOR ALL PATIENTS. ABLATION OUTCOMES AND COMPLICATIONS WERE EVALUATED. THE PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO BASELINE VT INDUCIBILITY: GROUP 1 (NON INDUCIBLE, N = 18), GROUP 2 (1 VT MORPHOLOGY INDUCED, N = 53), AND GROUP 3 (>1 VT MORPHOLOGY INDUCED, N = 89). PATIENTS WHO HAD PREEXISTING HEMODYNAMIC INSTABILITY AND/OR HEART FAILURE WERE PLACED ON ECMO DURING THE PROCEDURE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CONTACT-FORCE (CF) ABLATION CATHETER: SMARTTOUCH, BIOSENSE WEBSTER. PENTARAY MULTI ELECTRODE DIAGNOSTIC CATHETER. SMARTTOUCH LINEAR DIAGNOSTIC CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ALL ASSOCIATED WITH THE LAPWI PROCEDURE. N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 4 INSTANCES OF CARDIAC TAMPONADE TREATED WITH PERICARDIOCENTESIS. 3 ARTERIAL PSEUDOANEURYSMS: 2 TREATED WITH SURGERY AND 1 TREATMENT UNKNOWN. 1 FEMORAL HEMATOMA- NO TREATMENT REQUIRED. 9 PATIENTS WITH ACUTE HEMODYNAMIC DECOMPENSATION TREATED WITH INOTROPIC DRUGS. OF THESE 9, TWO DIED DUE TO REFRACTORY CARDIOGENIC SHOCK ASSOCIATED WITH LVAD IMPLANTATION AND ONE AFTER CARDIAC TRANSPLANTATION. THE AUTHORS DO NOT ATTRIBUTE THESE DEATHS TO THE DEVICES OR THE PROCEDURE. 1 PATIENT DIED AFTER AN ACUTE CORONARY OCCLUSION (PROXIMAL LEFT ANTERIOR DESCENDING ARTERY) DURING THE PROCEDURE WHICH WAS IMMEDIATELY STENTED BUT RESULTING IN REFRACTORY CARDIOGENIC SHOCK. THE MANUFACTURER OF THE STENT WAS UNKNOWN. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473686 UNK_PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening