BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15299504 · Received August 26, 2022

    Report

    Report Number
    2029046-2022-01985
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: KIM M, PARK YJ, YU HT, KIM TH, UHM JS, JOUNG B, PAK HN, LEE MH. CASE REPORT: DELAYED VENTRICULAR PSEUDOANEURYSM AFTER RADIOFREQUENCY ABLATION OF LEFT POSTEROMEDIAL PAPILLARY MUSCLE VENTRICULAR TACHYCARDIA. FRONT CARDIOVASC MED. 2022 JUN 15;9:887190. DOI: 10.3389/FCVM.2022.887190. PMID: 35783824; PMCID: PMC9240706. 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 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM M, PARK YJ, YU HT, KIM TH, UHM JS, JOUNG B, PAK HN, LEE MH. CASE REPORT: DELAYED VENTRICULAR PSEUDOANEURYSM AFTER RADIOFREQUENCY ABLATION OF LEFT POSTEROMEDIAL PAPILLARY MUSCLE VENTRICULAR TACHYCARDIA. FRONT CARDIOVASC MED. 2022 JUN 15;9:887190. DOI: 10.3389/FCVM.2022.887190. PMID: 35783824; PMCID: PMC9240706. OBJECTIVE/METHODS/STUDY DATA: -A 74-YEAR-OLD WOMAN PRESENTED WITH INCESSANT WIDE COMPLEX TACHYCARDIA THAT WAS REFRACTORY TO CARDIOVERSIONS. SUCCESSFUL RADIOFREQUENCY CATHETER ABLATION WAS PERFORMED ON THE LEFT VENTRICULAR POSTEROMEDIAL PAPILLARY MUSCLE. AN INAUDIBLE STEAM POP HAS OCCURRED DURING THE PROCEDURE, BUT WE CONFIRMED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND SHORT-TERM FOLLOW-UP OF ECHOCARDIOGRAPHY. TWO MONTHS AFTER THE PROCEDURE, AN ASYMPTOMATIC PSEUDOANEURYSM WAS IDENTIFIED AT THE ABLATION SITE THAT HAD NOT BEEN OBSERVED IN THE SHORT-TERM FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH, BIOSENSE WEBSTER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO-3 SYSTEM (BIOSENSE WEBSTER) . NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: -A 74-YEAR-OLD FEMALE PATIENT SUFFERED DELAYED LV PSEUDOANEURYSM (VASCULAR PSEUDOANEURYSM) CONFIRMED BY ECHOCARDIOGRAPHY AND CARDIAC CT THAT DEVELOPED ON AN INAUDIBLE STEAM POP SITE OCCURRING DURING ABLATION FOR THE TREATMENT OF VT ORIGINATING FROM THE PAPILLARY MUSCLE OF THE LV. THE PATIENT WAS ASYMPTOMATIC; THEREFORE, SHE WAS REFERRED TO THE OUTPATIENT CLINIC FOR OBSERVATIONAL FOLLOW-UP DURING THE FOLLOWING YEAR WITHOUT ANTICOAGULATION OR ANTIPLATELET AGENTS; THE PATIENT UNDERWENT NO FURTHER INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472143 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO-3 SYSTEM (BIOSENSE WEBSTER)