BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 20104993 · Received August 30, 2024

    Report

    Report Number
    2029046-2024-02918
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    August 1, 2022
    Report Date
    August 30, 2024
    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 CITE HAS BEEN REVIEWED: VÁZQUEZ-CALVO S, GARRE P, SANCHEZ-SOMONTE P, BORRAS R, QUINTO L, CAIXAL G, PUJOL-LOPEZ M, ALTHOFF T, GUASCH E, ARBELO E, TOLOSANA JM, BRUGADA J, MONT L, ROCA-LUQUE I. ORTHOGONAL HIGH-DENSITY MAPPING WITH VENTRICULAR TACHYCARDIA ISTHMUS ANALYSIS VS. PURE SUBSTRATE VENTRICULAR TACHYCARDIA ABLATION: A CASE-CONTROL STUDY. FRONT CARDIOVASC MED. 2022 AUG 1;9:912335. DOI: 10.3389/FCVM.2022.912335. PMID: 35979023; PMCID: PMC9376368. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. 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: VÁZQUEZ-CALVO S, GARRE P, SANCHEZ-SOMONTE P, BORRAS R, QUINTO L, CAIXAL G, PUJOL-LOPEZ M, ALTHOFF T, GUASCH E, ARBELO E, TOLOSANA JM, BRUGADA J, MONT L, ROCA-LUQUE I. ORTHOGONAL HIGH-DENSITY MAPPING WITH VENTRICULAR TACHYCARDIA ISTHMUS ANALYSIS VS. PURE SUBSTRATE VENTRICULAR TACHYCARDIA ABLATION: A CASE-CONTROL STUDY. FRONT CARDIOVASC MED. 2022 AUG 1;9:912335. DOI: 10.3389/FCVM.2022.912335. PMID: 35979023; PMCID: PMC9376368. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: SUBSTRATE-BASED ABLATION HAS BECOME A SUCCESSFUL TECHNIQUE FOR VENTRICULAR TACHYCARDIA (VT) ABLATION. HIGH-DENSITY (HD) MAPPING CATHETERS PROVIDE HIGH-RESOLUTION ELECTROANATOMICAL MAPS AND BETTER DISCRIMINATION OF LOCAL ABNORMAL ELECTROGRAMS. THE HD GRID MAPPING CATHETER IS AN HD CATHETER WITH THE ABILITY TO MAP ORTHOGONAL SIGNALS ON TOP OF CONVENTIONAL BIPOLAR SIGNALS, WHICH COULD PROVIDE BETTER DISCRIMINATION OF THE ARRHYTHMIC SUBSTRATE. ON THE OTHER HAND, CONVENTIONAL MAPPING TECHNIQUES, SUCH AS ACTIVATION MAPPING, WHEN POSSIBLE, HELP TO IDENTIFY THE ISTHMUS OF THE TACHYCARDIA. AIM: THE PURPOSE OF THIS STUDY WAS TO COMPARE CLINICAL OUTCOMES AFTER USING TWO DIFFERENT VT ABLATION STRATEGIES: ONE BASED ON EXTENSIVE MAPPING WITH THE HD GRID MAPPING CATHETER, INCLUDING VT ISTHMUS ANALYSIS, AND THE OTHER BASED ON PURE SUBSTRATE ABLATION. METHODS: 40 CONSECUTIVE PATIENTS UNDERGOING VT ABLATION WITH EXTENSIVE HD MAPPING METHOD IN THE HOSPITAL CLINIC (NOVEMBER 2018¿NOVEMBER 2019) WERE INCLUDED. CLINICAL OUTCOMES WERE COMPARED WITH A HISTORICAL COHORT OF 26 CONSECUTIVE PATIENTS WHO UNDERWENT ABLATION USING A SCAR DECHANNELING TECHNIQUE BEFORE 2018. RESULTS: THE DENSITY OF MAPPING POINTS WAS HIGHER IN THE EXTENSIVE MAPPING GROUP (2370.24 +/- 920.78 VS. 576.45 +/- 294.46; P < 0.001). AFTER 1 YEAR OF FOLLOW-UP, VT RECURRED IN 18.4% OF PATIENTS IN THE EXTENSIVE MAPPING GROUP VS. 34.6% OF PATIENTS IN THE HISTORICAL CONTROL GROUP (P = 0.14), WITH A SIGNIFICANTLY GREATER REDUCTION OF VT BURDEN: VT EPISODES (81.7 +/- 7.79 VS. 43.4 +/-19.9%, P < 0.05), ANTITACHYCARDIA PACING (99.45 +/- 2.29 VS. 33.9 +/-102.5%, P < 0.001), AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS (99 +/- 4.5 VS. 64.7 +/-59.9%, P = 0.02). CONCLUSION: THE USE OF A METHOD BASED ON EXTENSIVE MAPPING WITH THE HD GRID MAPPING CATHETER AND VT ISTHMUS ANALYSIS ALLOWS BETTER DISCRIMINATION OF THE ARRHYTHMIC SUBSTRATE AND COULD BE ASSOCIATED WITH A GREATER DECREASE IN VT BURDEN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK: THERMOCOOL SMARTTOUCH ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO 3 SYSTEM, PENTARAY CATHETER A FEMORAL HEMATOMA WAS REPORTED, BUT THE SHEATH USED WAS NOT IDENTIFIED TO BE BWI. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER -(QTY 1) 1 PATIENT HAD A COMPLETE ATRIOVENTRICULAR BLOCK. TREATMENT WAS NOT REPORTED. -(QTY 1) 1 PATIENT HAD AN ISCHEMIC STROKE. TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766201 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO 3 SYSTEM| PENTARAY CATHETER| UNKNOWN SHEATH