BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 19264395 · Received May 7, 2024

    Report

    Report Number
    2029046-2024-01497
    Event Type
    Death
    Date Received
    May 7, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: HASEGAWA K, YONEDA ZT, POWERS EM, TOKUTAKE K, KURATA M, RICHARDSON TD, MONTGOMERY JA, SHEN S, ESTRADA JC, SAAVEDRA PJ, EMERSON A, WALKER ML, TANDRI H, MICHAUD GF, KANAGASUNDRAM AN, STEVENSON WG. SAFETY OF VENTRICULAR ARRHYTHMIA RADIOFREQUENCY ABLATION WITH HALF-NORMAL SALINE IRRIGATION. EUROPACE. 2024 FEB 1;26(2):EUAE018. DOI: 10.1093/EUROPACE/EUAE018. PMID: (B)(4); PMCID: (B)(4). 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HASEGAWA K, YONEDA ZT, POWERS EM, TOKUTAKE K, KURATA M, RICHARDSON TD, MONTGOMERY JA, SHEN S, ESTRADA JC, SAAVEDRA PJ, EMERSON A, WALKER ML, TANDRI H, MICHAUD GF, KANAGASUNDRAM AN, STEVENSON WG. SAFETY OF VENTRICULAR ARRHYTHMIA RADIOFREQUENCY ABLATION WITH HALF-NORMAL SALINE IRRIGATION. EUROPACE. 2024 FEB 1;26(2):EUAE018. DOI: 10.1093/EUROPACE/EUAE018. PMID: (B)(4); PMCID: (B)(4). OBJECTIVE/METHODS/STUDY DATA: AIMS FAILURE OF RADIOFREQUENCY (RF) ABLATION OF VENTRICULAR ARRHYTHMIAS IS OFTEN DUE TO INADEQUATE LESION SIZE. IRRIGATED RF ABLATION WITH HALF-NORMAL SALINE (HNS) HAS THE POTENTIAL TO INCREASE LESION SIZE AND REDUCE SODIUM DELIVERY TO THE PATIENT IF THE SAME VOLUME OF RF IRRIGANT WERE USED FOR NORMAL SALINE (NS) AND HNS BUT COULD INCREASE RISKS RELATED TO STEAM POPS AND LESION SIZE. THIS STUDY AIMS TO ASSESS PERIPROCEDURAL COMPLICATIONS AND ACUTE ABLATION OUTCOME OF VENTRICULAR ARRHYTHMIAS ABLATION WITH HNS. METHODS AND RESULTS PROSPECTIVE ASSESSMENT OF OUTCOMES WAS PERFORMED IN 1024 ENDOCARDIAL AND/OR EPICARDIAL RF ABLATION PROCEDURES IN 935 CONSECUTIVE PATIENTS (MEDIAN AGE 64 YEARS, 71.2% MEN, 73.4% CARDIOMYOPATHY, 47.2% SUSTAINED VENTRICULAR TACHYCARDIA). HALF-NORMAL SALINE WAS SELECTED AT THE DISCRETION OF THE TREATING PHYSICIAN. RADIOFREQUENCY ABLATION POWER WAS GENERALLY TITRATED TO A =15 O IMPEDANCE FALL WITH INTRACARDIAC ECHOCARDIOGRAPHY MONITORING. HALF-NORMAL SALINE WAS USED IN 900 (87.9%) AND NS IN 124 (12.1%) PROCEDURES. ANY ADVERSE EVENT WITHIN 30 DAYS OCCURRED IN 13.0% OF PATIENTS TREATED WITH HNS RF ABLATION INCLUDING 4 (0.4%) STROKES/TRANSIENT ISCHAEMIC ATTACKS AND 34 (3.8%) PERICARDIAL EFFUSIONS REQUIRING TREATMENT (MOSTLY RELATED TO EPICARDIAL ACCESS). TWO STEAM POPS WITH PERFORATION REQUIRED SURGICAL REPAIR (0.2%). PATIENTS WHO RECEIVED NS IRRIGATION HAD LESS SEVERE DISEASE AND ARRHYTHMIAS. IN MULTIVARIABLE MODELS, ADVERSE EVENTS AND ACUTE SUCCESS OF THE PROCEDURE WERE NOT RELATED TO THE TYPE OF IRRIGATION. CONCLUSION HALF-NORMAL SALINE IRRIGATION RF ABLATION WITH POWER GUIDED BY IMPEDANCE FALL AND INTRACARDIAC ECHOCARDIOGRAPHY HAS AN ACCEPTABLE RATE OF COMPLICATIONS AND ACUTE ABLATION SUCCESS WHILE ADMINISTERING HALF OF THE SALINE LOAD EXPECTED FOR NS IRRIGATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: DECANAV, PENTARAY, THERMOCOOL, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOUCH SF, SOUNDSTAR CATHETER, CARTO, STOCKERT GENERATOR NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8 FR DEFLECTABLE SHEATH AGILIS (ABBOT), PRECISION (ABBOT), ENSITE (ABBOT), TACTICATH (ABBOTT), FLEXABILITY (ABBOTT), CARDIOLAB (GENERAL ELECTRIC HEALTHCARE), IBI 500T (ABBOT). THE VASCULAR ACCESS COMPLICATIONS ARE ASSOCIATED WITH THE SHEATH, WHICH THE ARTICLE INDICATED WAS A NON BWI PRODUCT (AGILIS SHEATH). EPICARDIAL ACCESS COMPLICATIONS ARE ASSOCIATED WITH THE NEEDLES USED FOR EPICARDIAL ACCESS (17 GAUGE TUOHY OR 18 GAUGE COOK NEEDLE THROUGH A 21 GAUGE MICROPUNCTURE NEEDLE FOR THE NEEDLE-IN-NEEDLE TECHNIQUE) AS WELL AS THE SHEATH. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH: QTY 25 PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS (CARDIAC TAMPONADE) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 6 PERICARDIAL EFFUSION FROM VENTRICULAR LACERATION TREATED WITH SURGICAL REPAIR (CARDIAC TAMPONADE) (SURGICAL INTERVENTION) (ADVERSE EVENT). QTY 2 CARDIAC PERFORATION WITH STEAM POP AND POSSIBLE SURGICAL INTERVENTION (CARDIAC PERFORATION) (SURGICAL INTERVENTION) (STEAM POP) (ADVERSE EVENT). QTY 1 TRANSIENT ISCHEMIC ATTACK WITH UNKNOWN INTERVENTION (TIA) (RECOGNIZED PROCEDURAL COMPLICATION) ( ADVERSE EVENT). QTY 1 CEREBROVASCULAR ACCIDENT WITH UNKNOWN TREATMENT (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1 EMBOLISM WITH UNKNOWN TREATMENT (EMBOLISM) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1 PULMONARY EMBOLISM / DVT WITH UNKNOWN TREATMENT (THROMBOEMBOLISM) ( RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1 HIGH-DEGREE HEART BLOCK WITH UNKNOWN TREATMENT (HEART BLOCK AV) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 23 HEART FAILURE WITH UNKNOWN TREATMENT (CARDIAC FAILURE) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1 HEMATURIA (HEMATURIA) (SERIOUS INJURY) ( ADVERSE EVENT). QTY 1 PNEUMONIA (PNEUMONIA)(RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1 DEATH FROM SEVERE HEART FAILURE (CARDIAC FAILURE) (DEATH) (ADVERSE EVENT ¿ DEATH). QTY 1 DEATH FROM PNEUMONIA AND SEPSIS (SEPSIS) ( PNEUMONIA) (DEATH) (ADVERSE EVENT-DEATH). QTY 1 DEATH FROM CEREBRAL HEMORRHAGE (CEREBROVASCULAR ACCIDENT) ( DEATH) (ADVERSE EVENT ¿ DEATH). QTY 1 DEATH FROM GASTROINTESTINAL BLEEDING (BLEEDING) (DEATH) (ADVERSE EVENT -DEATH). QTY 1 DEATH FROM UROSEPSIS (SEPSIS) (DEATH) (ADVERSE EVENT ¿ DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670970 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L| H| R