BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15682635 · Received October 27, 2022

    Report

    Report Number
    2029046-2022-02661
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    May 25, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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 CITATION HAS BEEN REVIEWED: RAJENDRA A, HUNTER TD, MORALES GX, ZEI P, BOO LM, VARLEY A, OSORIO J. STEERABLE SHEATH VISUALIZABLE UNDER 3D ELECTROANATOMICAL MAPPING FACILITATES PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH MINIMAL FLUOROSCOPY. J INTERV CARD ELECTROPHYSIOL. 2022 AUG 10. DOI: 10.1007/S10840-022-01332-8. EPUB AHEAD OF PRINT. ERRATUM IN: J INTERV CARD ELECTROPHYSIOL. 2022 SEP 6;: PMID: 35947317. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME ARTICLE. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: RAJENDRA A, HUNTER TD, MORALES GX, ZEI P, BOO LM, VARLEY A, OSORIO J. STEERABLE SHEATH VISUALIZABLE UNDER 3D ELECTROANATOMICAL MAPPING FACILITATES PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH MINIMAL FLUOROSCOPY. J INTERV CARD ELECTROPHYSIOL. 2022 AUG 10. DOI: 10.1007/S10840-022-01332-8. EPUB AHEAD OF PRINT. ERRATUM IN: J INTERV CARD ELECTROPHYSIOL. 2022 SEP 6;: PMID: 35947317. OBJECTIVE/METHODS/STUDY DATA:THE OBJECTIVE OF THIS STUDY WAS TO DEMONSTRATE FEASIBILITY, SAFETY, PROCEDURAL EFFICIENCY, AND CLINICAL EFFECTIVENESS OF INCORPORATING THE NEW VISUALIZABLE SHEATH INTO A LOW-FLUOROSCOPY WORKFLOW.THE STUDY POPULATION INCLUDED PATIENTS HAVING DE NOVO PAF ABLATION PERFORMED BY ONE OF THREE OPERATORS AT A SINGLE HIGH VOLUME SITE BETWEEN JANUARY 2018 AND MAY 2019. COHORTS OF INTEREST WERE DEFINED BY PROCEDURES THAT UTILIZED A VIZIGO SHEATH VIZIGO COHORT) VERSUS THOSE THAT DID NOT (NON-VIZIGO COHORT). ALL PATIENTS UNDERWENT THEIR FIRST LEFT ATRIAL ABLATION WITH THE THERMOCOOL SMARTTOUCH® SF CATHETER (STSF; BIOSENSE WEBSTER, INC., IRVINE, CA) AND WERE EVALUATED ACCORDING TO STANDARD CLINICAL PRACTICES AT THE STUDY SITE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH® SF CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO VISITAG¿ SHEATH NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: FAST-CATH SL2 PREFORMED SHEATH (SL2; ST. JUDE MEDICAL, INC., ST. PAUL, MN), PINNACLE INTRODUCER SHEATH (TERUMO MEDICAL CORPORATION, ELKTON, MD), MULTIPOLAR PENTARAY CATHETER (BIOSENSE WEBSTER, INC.,IRVINE, CA), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1- ARTERIOVENOUS FISTULA (VIZIGO COHORT). QTY 2- CARDIAC TAMPONADE ( 1 IN VIZIGO COHORT AND 1 IN NON-VIZIGO COHORT REQUIRING PERICARDIOCENTESIS). QTY 2 - HEMATOMA (VIZIGO COHORT). QTY 2 - PSEUDOANEURYSM (1 IN VIZIGO COHORT AND 1 IN NON-VIZIGO COHORT REQUIRING FEMORAL ARTERY REPAIR.). QTY 1- PERICARDITIS (VIZIGO COHORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510999 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening FAST-CATH SL2 PREFORMED SHEATH| MULTIPOLAR PENTARAY CATHETER| PINNACLE INTRODUCER SHEATH