BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15565403 · Received October 7, 2022

    Report

    Report Number
    2029046-2022-02431
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    October 26, 2020
    Report Date
    October 7, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: FERNANDEZ-ARMENTA J, SOTO-IGLESIAS D, SILVA E, PENELA D, JÁUREGUI B, LINHART M, BISBAL F, ACOSTA J, FERNANDEZ M, BORRAS R, VILLUENDAS R, CANO L, GUASCH E, MONT L, BERRUEZO A. SAFETY AND OUTCOMES OF VENTRICULAR TACHYCARDIA SUBSTRATE ABLATION DURING SINUS RHYTHM: A PROSPECTIVE MULTICENTER REGISTRY. JACC CLIN ELECTROPHYSIOL. 2020 OCT 26;6(11):1435-1448. DOI: 10.1016/J.JACEP.2020.07.028. PMID: 33121673. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER (D133601) APPROVED UNDER PMA # P030031/S053. 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 NOT PROVIDED BY THE CUSTOMER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-(B)(4). HAS TWO REPORTS: (1) MFR # 2029046-2022-02431 FOR PRODUCT CODE UNK (SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER) (2) MFR # 2029046-2022-02429 FOR PRODUCT CODE UNK (SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: FERNANDEZ-ARMENTA J, SOTO-IGLESIAS D, SILVA E, PENELA D, JÁUREGUI B, LINHART M, BISBAL F, ACOSTA J, FERNANDEZ M, BORRAS R, VILLUENDAS R, CANO L, GUASCH E, MONT L, BERRUEZO A. SAFETY AND OUTCOMES OF VENTRICULAR TACHYCARDIA SUBSTRATE ABLATION DURING SINUS RHYTHM: A PROSPECTIVE MULTICENTER REGISTRY. JACC CLIN ELECTROPHYSIOL. 2020 OCT 26;6(11):1435-1448. DOI: 10.1016/J.JACEP.2020.07.028. PMID: 33121673. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY SOUGHT TO ANALYZE SAFETY AND OUTCOMES OF VENTRICULAR TACHYCARDIA (VT) SUBSTRATE ABLATION DURING SINUS RHYTHM (SR), WITHOUT BASELINE VT INDUCTION. ALL CONSECUTIVE PATIENTS (N ¼ 412) UNDERGOING SCAR-RELATED VT ABLATION IN 6 CENTERS WERE INCLUDED. THIS IS A PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY OF SUBSTRATE-GUIDED VT ABLATION DURING SINUS RHYTHM. THE AIM OF THIS REGISTRY IS TO EVALUATE THE SAFETY AND SHORT- AND LONG-TERM OUTCOMES OF VT SUBSTRATE ABLATION, BY MEANS OF SCAR DECHANNELING, IN PATIENTS WITH SHD FOLLOWING AN ABLATION PROTOCOL STARTING WITH SUBSTRATE ABLATION DURING STABLE RHYTHM (SINUS OR PACED). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL NAVISTAR OR SMARTTOUCH, BIOSENSE WEBSTER-- FOR REPORTABILITY PURPOSES, THIS WILL BE CODED AS UNK_SMART TOUCH UNIDIRECTIONAL. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 ,MULTIPOLAR CATHETER (PENTARAY, BIOSENSE WEBSTER) NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BRK NEEDLE, MEDTRONIC, MINNEAPOLIS, MINNESOTA), CIIRCO PROBE ENGLEWOOD, ARCTIC FRONT ADVANCE MEDTRONIC, SPIRAL MAPPING CATHETER( ACHIEVE MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 3 SEVERE ACUTE HEMODYNAMIC DECOMPENSATION RESOLVED WITH STANDARD SUPPORT MEASURES AND REQUIRED PROCEDURE TERMINATION ( CODED AS CARDIAC ARREST REQUIRING CPR) . QTY 6- HEART BLOCK -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 5- PUNCTURE HEMATOMA -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 6- CARDIAC TAMPONADE -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 3- STROKE/TIA -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 3- PHRENIC NERVE PALSY -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 1- TRANSIENT ST-SEGMENT ELEVATION -NO FURTHER INFORMATION PROVIDED REGARDING INTERVENTIONS OR OUTCOME. QTY 1- DEATH DUE TO PULSELESS ELECTRICAL ACTIVITY NOT RESPONDING TO ADVANCED RESUSCITATION MANEUVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888992 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening BRK NEEDLE, MEDTRONIC, MINNEAPOLIS, MINNESOTA)| CIIRCO PROBLE ENGLEWOOD, ARCTIC FRONT ADVANCE| MULTIPOLAR CATHETER (PENTARAY, BIOSENSE WEBSTER)| SPIRL MAPPING CATHETER( ACHIEVE MEDTRONIC)| UNK_CARTO 3