BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20092785 · Received August 28, 2024

    Report

    Report Number
    2029046-2024-02878
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: MAVILAKANDY A, KOEV I, SIDHU B, KOTB A, ANTOUN I, MAN SH, VALI Z, POORANACHANDRAN V, BARKER J, PANCHAL G, LI X, NG GA. THE FEASIBILITY, SAFETY AND OUTCOME OF VERY HIGH-POWER SHORT DURATION RADIOFREQUENCY ABLATION IN PULMONARY VEIN ISOLATION: A REAL-WORLD OBSERVATION STUDY. REV CARDIOVASC MED. 2024 JUL 5;25(7):250. DOI: 10.31083/J.RCM2507250. PMID: 39139441; PMCID: PMC11317307. 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 NO LOT NUMBER WAS 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. 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: MAVILAKANDY A, KOEV I, SIDHU B, KOTB A, ANTOUN I, MAN SH, VALI Z, POORANACHANDRAN V, BARKER J, PANCHAL G, LI X, NG GA. THE FEASIBILITY, SAFETY AND OUTCOME OF VERY HIGH-POWER SHORT DURATION RADIOFREQUENCY ABLATION IN PULMONARY VEIN ISOLATION: A REAL-WORLD OBSERVATION STUDY. REV CARDIOVASC MED. 2024 JUL 5;25(7):250. DOI: 10.31083/J.RCM2507250. PMID: 39139441; PMCID: PMC11317307. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: PULMONARY VEIN ISOLATION (PVI) ABLATION IS THE ESTABLISHED GOLD STANDARD THERAPY FOR PATIENTS WITH SYMPTOMATIC DRUG REFRACTORY ATRIAL FIBRILLATION (AF). ADVANCEMENTS IN RADIOFREQUENCY (RF) ABLATION, HAVE LED TO THE DEVELOPMENT OF THE NOVEL CONTACT FORCE-SENSING TEMPERATURE-CONTROLLED VERY HIGH-POWER SHORT-DURATION (VHPSD) RF ABLATION. THIS SETTING DELIVERS 90 W FOR UP TO 4 SECONDS WITH A CONSTANT IRRIGATION FLOW RATE OF 8 ML/MIN. THE AIM OF THIS STUDY WAS TO COMPARE PROCEDURAL OUTCOMES AND SAFETY WITH CONVENTIONAL RADIOFREQUENCY ABLATION. METHODS: AN OBSERVATIONAL STUDY WAS CONDUCTED WITH PATIENTS WHO UNDERWENT FIRST TIME PVI ABLATION BETWEEN AUGUST 2020 AND JANUARY 2022. THE COHORT WAS DIVIDED INTO: (1) VHPSD ABLATION; (2) HIGH-POWER SHORT DURATION (HPSD) ABLATION; (3) THERMOCOOL SMARTTOUCH¿ SF (STSF). THE VHPSD ABLATION GROUP WAS PROSPECTIVELY RECRUITED WHILE THE HPSD AND STSF GROUP WERE RETROSPECTIVELY COLLECTED. PRIMARY OUTCOMES WERE PROCEDURAL SUCCESS, PVI DURATION, ABLATION DURATION AND INCIDENCE OF PERIOPERATIVE ADVERSE EVENTS. SECONDARY OUTCOMES WERE INTRAPROCEDURAL MORPHINE AND MIDAZOLAM REQUIREMENT. RESULTS: A TOTAL OF 175 PATIENTS WERE INCLUDED IN THE STUDY WITH 100, 30 AND 45 PATIENTS IN THE VHPSD, HPSD AND STSF GROUP, RESPECTIVELY. PVI WAS SUCCESSFULLY ATTAINED IN ALL VHPSD PATIENTS. VHPSD DEMONSTRATED SIGNIFICANTLY REDUCED TIME REQUIRED FOR PVI AND TOTAL ENERGY APPLICATION IN COMPARISON TO THE HPSD AND STSF GROUPS (67.7 ± 29.7 VS. 92.9 ± 25.7 VS. 93.6 ± 29.1 MIN, P < 0.0001; 9.87 ± 4.16 VS. 33.9 ± 7.49 VS. 36.0 ± 10.5 MIN, P < 0.0001, RESPECTIVELY). INTRAVENOUS MORPHINE AND MIDAZOLAM REQUIREMENT WAS LOWER IN THE VHPSD GROUP COMPARED TO THE HPSD AND STSF GROUPS (10.2 ± 3.43 VS. 16.1 ± 4.58 VS. 15.3 ± 3.94 MG, P < 0.0001; 4.04 ± 3.24 VS. 8.63 ± 5.22 VS. 8.58 ± 4.72 MG, P < 0.0001). ONE CARDIAC TAMPONADE WAS OBSERVED IN BOTH THE VHPSD AND HPSD GROUPS WHILE THE STSF GROUP EXHIBITED AN EMBOLIC STOKE AND TWO PERICARDIAL EFFUSIONS THAT DID NOT REQUIRE DRAINAGE. CONCLUSIONS: IN THIS STUDY, VHPSD DEMONSTRATED A COMPARABLE SAFETY PROFILE TO THE OTHER TREATMENT ARMS. PROCEDURAL DURATION AND ENERGY APPLICATION TIME WAS SUBSTANTIALLY REDUCED ALONG WITH SEDATION REQUIREMENT NOTWITHSTANDING THE LIMITATIONS OF OBSERVATIONAL STUDY DESIGN, THESE PRELIMINARY FINDINGS ARE PROMISING WITH RESPECT TO PERIPROCEDURAL OUTCOMES AND SAFETY OF VHPSD HOWEVER LONGITUDINAL OUTCOMES WILL BE ESSENTIAL TO ASSESSING THE OVERALL EFFICACY OF THIS NOVEL TECHNOLOGY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT AND THERMOCOOL SMARTTOUCH SF. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO, LASSO, PENTARAY. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LABSYSTEM PRO (BOSTON SCIENTIFIC). ACCESS SITE HEMATOMA WAS REPORTED HOWEVER THE SHEATH ASSOCIATED WITH VASCULAR ACCESS SITE COMPLICATIONS WAS NOT IDENTIFIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT: QTY 1 - HAEMORRHAGIC PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE, WHICH WAS IMMEDIATELY TREATED WITH PERICARDIOCENTESIS AND INITIATION OF THE MAJOR HAEMORRHAGE PROTOCOL, INCLUDING TRANSFUSION OF PACKED RED CELLS AND PROTHROMBIN COMPLEX CONCENTRATE. HAEMODYNAMIC STABILITY WAS PROMPTLY ATTAINED AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU) AND MADE A GOOD CLINICAL RECOVERY WITH NO SUBSEQUENT RE-HOSPITALIZATION NOTED. QTY 1 - A 2:1 ATRIOVENTRICULAR BLOCK THAT OCCURRED FOLLOWING THE ABLATION OF A SLOW PATHWAY SUBSEQUENT TO PVI FOR TREATMENT OF INCESSANT ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVRNT) AND PAROXYSMAL ATRIAL FIBRILLATION (PAF). A TEMPORARY PACING WIRE WAS INSERTED FOLLOWED BY A DUAL CHAMBER PERMANENT PACEMAKER A FEW DAYS LATER. QTY 1 ¿ CARDIAC TAMPONADE WHICH REQUIRED IMMEDIATE PERICARDIAL DRAIN INSERTION. THE PATIENT MADE A FULL RECOVERY FOLLOWING A PERIOD OF MONITORING IN A HIGH-DEPENDENCY UNIT SETTING. NONSERIOUS EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT: QTY 1 - TRANSIENT EPISODE OF JUNCTIONAL RHYTHM WITH SINUS BRADYCARDIA. AN EXERCISE TOLERANCE TEST CONDUCTED 48 HOURS LATER DID NOT REVEAL ANY PERSISTENT ATRIOVENTRICULAR (AV) BLOCK REQUIRING PACEMAKER INSERTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF: QTY 1 ¿ CARDIAC TAMPONADE, REQUIRING PERICARDIAL DRAIN; THE CARDIAC TAMPONADE OCCURRED FOLLOWING A TRANSOESOPHAGEAL ECHOCARDIOGRAM AND PVI UNDER GENERAL ANAESTHESIA, A POST-PROCEDURAL TRANSTHORACIC ECHOCARDIOGRAM (TTE) IDENTIFIED A SEVERE PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIAL DRAIN, FOLLOWING WHICH THE PATIENT HAD AN UNEVENTFUL RECOVERY. QTY 1 ¿ SUSPECTED LEFT ANTERIOR CIRCULATION STROKE; THE SUSPECTED CEREBROVASCULAR ACCIDENT (CVA) OCCURRED FOLLOWING PVI AS THE PATIENT EXPERIENCED LEFT-SIDED WEAKNESS AND WAS SUBSEQUENTLY TRANSFERRED TO THE STROKE UNIT. FOLLOWING A PERIOD OF OBSERVATION, THE PATIENT MADE A FULL RECOVERY. NONSERIOUS EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF: QTY 1 ¿ PERICARDIAL EFFUSION NOT REQUIRING DRAINAGE; SMALL PERICARDIAL EFFUSION WAS NOTED ON ROUTINE POSTPROCEDURE TTE. A PERIOD OF MONITORING FOLLOWED BY A REPEAT TTE THE NEXT DAY REVEALED NO EVIDENCE OF PROGRESSION OF THE PERICARDIAL EFFUSION OR HAEMODYNAMIC COMPROMISE AND HENCE DID NOT REQUIRE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464571 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L| H CARTO| LABSYSTEM PRO (BOSTON SCIENTIFIC)| LASSO| PENTARAY