BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 14684807 · Received June 14, 2022

    Report

    Report Number
    2029046-2022-01293
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    March 23, 2021
    Report Date
    June 14, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: TAKAGI T, PAMBRUN T, NAKASHIMA T, VLACHOS K, ANDRÉ C, KRISAI P, RAMIREZ FD, KAMAKURA T, NAKATANI Y, CHENITI G, TIXIER R, CHAUVEL R, DUCHATEAU J, SACHER F, COCHET H, HOCINI M, HAÏSSAGUERRE M, JAÏS P, DERVAL N. SIGNIFICANCE OF MANIFEST LOCALIZED STAINING DURING ETHANOL INFUSION INTO THE VEIN OF MARSHALL. HEART RHYTHM. 2021 JUL;18(7):1057-1063. DOI: 10.1016/J.HRTHM.2021.03.023. EPUB 2021 MAR 16. PMID: 33741483. NOTE: THE LITERATURE ARTICLE'S ELECTRONIC FILE SIZE IS TOO LARGE TO BE ATTACHED AND SUBMITTED. 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. MANUFACTURER'S REF. # PC-001129657

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TAKAGI T, PAMBRUN T, NAKASHIMA T, VLACHOS K, ANDRÉ C, KRISAI P, RAMIREZ FD, KAMAKURA T, NAKATANI Y, CHENITI G, TIXIER R, CHAUVEL R, DUCHATEAU J, SACHER F, COCHET H, HOCINI M, HAÏSSAGUERRE M, JAÏS P, DERVAL N. SIGNIFICANCE OF MANIFEST LOCALIZED STAINING DURING ETHANOL INFUSION INTO THE VEIN OF MARSHALL. HEART RHYTHM. 2021 JUL;18(7):1057-1063. DOI: 10.1016/J.HRTHM.2021.03.023. EPUB 2021 MAR 16. PMID: 33741483. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND LOCALIZED STAINING DUE TO VENULE INJURY IS ATTRIBUTABLE TO ETHANOL INFUSION INTO THE VEIN OF MARSHALL (ET-VOM). OBJECTIVE THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE ADVERSE OUTCOMES OF LOCALIZED STAINING DURING ET-VOM IN PATIENTS UNDERGOING ABLATION FOR ATRIAL FIBRILLATION. METHODS TWO HUNDRED FOUR PATIENTS (AGE 64 PLUS OR MINUS 10 YEARS; 153 MALE) WERE SORTED BASED ON THE ASPECT OF LOCALIZED STAINING. STAINING OF ATRIAL MYOCARDIUM THAT SPREAD UNIFORMLY ALONG THE VOM VASCULAR TREE FOLLOWING SELECTIVE VOM VENOGRAPHY WAS CONSIDERED NORMAL, IN CONTRAST TO PREDOMINANTLY LOCALIZED STAINING THAT SPREAD CONCENTRICALLY FROM A FOCAL POINT DUE TO VASCULAR INJURY. OUTCOMES BETWEEN THE 2 GROUPS WERE COMPARED. RESULTS LOCALIZED STAINING WAS OBSERVED IN 27%OF PATIENTS. NO PATIENTS DEVELOPED CLINICALLY SIGNIFICANT PERICARDIAL EFFUSIONS DURING ET-VOM; HOWEVER, 7 PATIENTS DEVELOPED PERICARDIAL EFFUSIONS ON THE FIRST POSTPROCEDURAL DAY (3.6% IN PATIENTS WITH VS 3.4% IN PATIENTS WITHOUT LOCALIZED STAINING). NO SIGNIFICANT DIFFERENCE WAS FOUND IN ACHIEVEMENT OF ACUTE MITRAL ISTHMUS (MI) BLOCK (96% VS 98%) AND SIZE OF THE ENDOCARDIAL LOW-VOLTAGE AREA IN PATIENTS WITH AND WITHOUT LOCALIZED STAINING, RESPECTIVELY. LONG-TERM FOLLOW-UP WAS NOT IMPACTED BY LOCALIZED STAINING. FREEDOM FROM RECURRENT ATRIAL TACHYARRHYTHMIAS (66% VS 76%) AND DURABILITY OF MI BLOCK (57% VS 54%) WERE NOT SIGNIFICANTLY DIFFERENT WITH AND WITHOUT LOCALIZED STAINING. THERE WERE NO CASES OF REHOSPITALIZATION FOR PERICARDITIS, CHRONIC PERICARDIAL EFFUSION, OR HEART FAILURE. CONCLUSION IN OUR STUDY, LOCALIZED STAINING WAS FREQUENT BUT WAS NOT ASSOCIATED WITH CLINICALLY RELEVANT IMPACT OR DISADVANTAGES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF OR THERMOCOOL SF. OTHER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3. PENTARAY CATHETER. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: BALLOON CATHETER 145-CM MINI TREK, ABBOTT. RHYTHMIA, BOSTON SCIENTIFIC. 5F DECAPOLAR MAPPING CATHETER, BOSTON SCIENTIFIC. AGILIS NXT, ABBOTT. INTERNALMAMMARY ARTERY ANGIOGRAPHY CATHETER, MEDTRONIC. WHISPER 0.014-INCH, ABBOTT. SION BLUE 0.014, ASAHI. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: -ONE PATIENT HAD CARDIAC TAMPONADE THAT OCCURRED DURING RIGHT PV ISOLATION AND WAS EXCLUDED FROM THIS ANALYSIS. ADDITIONALLY, 7 SMALL PERICARDIAL EFFUSIONS IN 7 PATIENTS OCCURRED, INCLUDING 2 WITH LOCALIZED STAINING (3.6% VS 3.4% IN THE GROUPS WITH AND WITHOUT LOCALIZED STAINING, RESPECTIVELY; P .92). NONE REQUIRED PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789299 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R 5F DECAPOLAR MAPPING CATHETER, BOSTON SCIENTIFIC| AGILIS NXT, ABBOTT| BALLOON CATHETER 145-CM MINI TREK, ABBOTT| INTERNALMAMMARY ARTERY ANGIOGRAPHY CATHETER| RHYTHMIA, BOSTON SCIENTIFIC| SION BLUE 0.014, ASAHI| UNK_CARTO 3| UNK_PENTARAY| WHISPER 0.014-INCH, ABBOTT