BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18937808 · Received March 19, 2024

    Report

    Report Number
    2029046-2024-00929
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    November 15, 2022
    Report Date
    March 19, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: WANG Y, ZHAO Y, ZHOU K, ZEI PC, WANG Y, CHENG H, CHEN S, TAO Y, MAO Y, LIU Q, BANGASH AB, SHENG X, SUN Y, ZHANG P, YU L, LIN J, ZHANG Z, FU G, JIANG R, JIANG C. INTRACARDIAC ECHOCARDIOGRAPHY IS A SAFE AND EFFECTIVE ALTERNATIVE TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR LEFT ATRIAL APPENDAGE THROMBUS EVALUATION AT THE TIME OF ATRIAL FIBRILLATION ABLATION: THE ICE-TEE STUDY. PACING CLIN ELECTROPHYSIOL. 2023 JAN;46(1):3-10. DOI: 10.1111/PACE.14601. EPUB 2022 NOV 15. PMID: 36301182. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 26-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OF THE ARTICLE INDICATING THERE WAS NO RELEVANCE BETWEEN THE HARM AND THE BWI PRODUCT IN THE ARTICLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG Y, ZHAO Y, ZHOU K, ZEI PC, WANG Y, CHENG H, CHEN S, TAO Y, MAO Y, LIU Q, BANGASH AB, SHENG X, SUN Y, ZHANG P, YU L, LIN J, ZHANG Z, FU G, JIANG R, JIANG C. INTRACARDIAC ECHOCARDIOGRAPHY IS A SAFE AND EFFECTIVE ALTERNATIVE TO TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR LEFT ATRIAL APPENDAGE THROMBUS EVALUATION AT THE TIME OF ATRIAL FIBRILLATION ABLATION: THE ICE-TEE STUDY. PACING CLIN ELECTROPHYSIOL. 2023 JAN;46(1):3-10. DOI: 10.1111/PACE.14601. EPUB 2022 NOV 15. PMID: 36301182. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TECHNOLOGY HAS BEEN INCREASINGLY ACCEPTED AS AN INTEGRAL PART OF ATRIAL FIBRILLATION (AF) ABLATION PROCEDURES. IT IS STILL UNKNOWN WHETHER ICE CAN ROUTINELY REPLACE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR ROUTINE THROMBUS SCREENING IN NON-SELECTIVE AF PATIENTS. OBJECTIVE: TO ASSESS WHETHER ICE CAN ROUTINELY REPLACE TEE IN SCREENING FOR LEFT ATRIAL (LA)/LEFT ATRIAL APPENDAGE (LAA) THROMBUS IN GENERAL PATIENTS UNDERGOING CATHETER ABLATION FOR AF. METHODS: A TOTAL OF (B)(4) CONSECUTIVE PATIENTS UNDERGOING AF ABLATION WERE INCLUDED. (B)(4) PATIENTS (ICE GROUP) RECEIVED INTRA-PROCEDURAL ICE EXAMINATION FOR LA/LAA THROMBUS SCREENING, WHILE (B)(4) PATIENTS (TEE GROUP) RECEIVED PRE-PROCEDURE TEE EXAMINATION. THE INCIDENCE OF THROMBUS, PERI-PROCEDURE COMPLICATIONS, AND HOSPITAL EFFICIENCY WERE ASSESSED. RESULTS: THE LA AND LAA WERE ADEQUATELY VISUALIZED IN ALL PATIENTS. FIVE PATIENTS IN THE ICE GROUP AND (B)(4) PATIENTS IN THE TEE GROUP WERE FOUND TO HAVE LAA THROMBUS. THE INCIDENCE OF MAJOR PERIPROCEDURAL THROMBO-EMBOLIC EVENTS WAS COMPARABLE BETWEEN TWO GROUPS ((B)(4)), NONE WERE DUE TO UNDETECTED LA/LAA THROMBUS. OTHER MAJOR PERIPROCEDURAL COMPLICATIONS OCCURRED AT SIMILAR RATES IN BOTH GROUPS, WHILE POST-PROCEDURE FEVER WAS LESS COMMON IN THE ICE GROUP ((B)(4)). PROCEDURE TIMES AND HOSPITAL LENGTH OF STAY WERE BOTH SHORTER IN THE ICE GROUP (142 MIN [87-197 MIN] VS. 150 MIN [95-205 MIN], AND 3[2-4] DAY VS. 4[3-5] DAY, RESPECTIVELY, BOTH P (B)(4)). CONCLUSIONS: ICE CAN REPLACE TEE FOR ATRIAL THROMBUS SCREENING IN AF PATIENTS UNDERGOING ABLATION WITHOUT INCREASED COMPLICATIONS. AN "ICE REPLACING TEE" WORKFLOW CAN ALSO REDUCE THE INCIDENCE OF POSTOPERATIVE FEVER AND IMPROVE HOSPITAL EFFICIENCY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH ABLATION CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO MAPPING SYSTEM, PENTARAY MAPPING CATHETER, SOUNDSTAR ICE CATHETER, LASSO MAPPING CATHETER CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY USED IN TEE GROUP: VINGMED ULTRASOUND AS (GENERAL ELECTRIC). THE VASCULAR ACCESS COMPLICATIONS ARE ASSOCIATED WITH SHEATH USAGE AND THE ARTICLE DOES NOT DISCUSS/IDENTIFY SHEATHS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER: QTY (B)(4) (THROMBOSIS)(RECOGNIZED PROCEDURAL COMPLICATION QTY (B)(4) HEMODYNAMICALLY SIGNIFICANT PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS(CARDIAC TAMPONADE)(QTY (B)(4) RECOGNIZED PROCEDURAL COMPLICATION) WITH ONE REQUIRING PLACEMENT OF A PERICARDIAL DRAIN (QTY (B)(4) SURGICAL INTERVENTION) QTY (B)(4) STROKES (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION) QTY (B)(4) POST-PROCEDURAL FEVER (FEVER) WITH (B)(4) SHOWING LOW-GRADE AND RECOVERED AFTER REHYDRATION AND EMPIRIC ANTI-INFECTIVE THERAPY (APPROXIMATELY QTY (B)(4) MINOR INJURY) AND NO INFORMATION REGARDING THE REMAINING CASES (QTY (B)(4) INSUFFICIENT INFORMATION). DEATH ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER: QTY (B)(4) (CARDIAC PERFORATION) REQUIRING CARDIAC SURGERY (SURGICAL INTERVENTION) AND DIED (DEATH) DUE TO DISSEMINATED INTRAVASCULAR COAGULATION (EMBOLISM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487017 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO MAPPING SYSTEM| LASSO MAPPING CATHETER| PENTARAY MAPPING CATHETER| SOUNDSTAR ICE CATHETER| VINGMED ULTRASOUND AS (GENERAL ELECTRIC)