BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14388276 · Received May 13, 2022

    Report

    Report Number
    2029046-2022-01019
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    July 25, 2020
    Report Date
    May 12, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    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 CITE HAS BEEN REVIEWED: GHANNAM M, YOKOKAWA M, LIANG JJ, COCHET H, JAIS P, DABAGH GS, LATCHAMSETTY R, JONGNARANGSIN K, MORADY F, BOGUN F. CLINICAL SIGNIFICANCE OF MYOCARDIAL SCAR IN PATIENTS WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES UNDERGOING CATHETER ABLATION. HEART RHYTHM. 2021 JAN;18(1):20-26. DOI: 10.1016/J.HRTHM.2020.07.030. EPUB 2020 JUL 25. PMID: 32721479. 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. 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: GHANNAM M, YOKOKAWA M, LIANG JJ, COCHET H, JAIS P, DABAGH GS, LATCHAMSETTY R, JONGNARANGSIN K, MORADY F, BOGUN F. CLINICAL SIGNIFICANCE OF MYOCARDIAL SCAR IN PATIENTS WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES UNDERGOING CATHETER ABLATION. HEART RHYTHM. 2021 JAN;18(1):20-26. DOI: 10.1016/J.HRTHM.2020.07.030. EPUB 2020 JUL 25. PMID: 32721479. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE IMPACT OF FOCAL MYOCARDIAL SCARRING AS DETECTED BY CARDIAC MAGNETIC IMAGING ON PREMATURE VENTRICULAR COMPLEXES INDUCED CARDIOMYOPATHY, PROCEDURAL OUTCOMES, AND RECOVERY OF LEFT VENTRICULAR FUNCTION IN PATIENTS WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES. A TOTAL OF 351 CONSECUTIVE PATIENTS WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES REFERRED FOR ABLATION WERE INCLUDED. A CARDIAC MAGNETIC RESONANCE WAS PERFORMED IN ALL PATIENTS PRIOR TO THE ABLATION PROCEDURE. A =10% INCREASE IN EJECTION FRACTION OR NORMALIZATION OF A PREVIOUSLY ABNORMAL EJECTION FRACTION WAS DEFINED AS EVIDENCE OF PREMATURE VENTRICULAR COMPLEXES INDUCED CARDIOMYOPATHY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL NAVISTAR CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SIGNA EXCITE CV/I (GENERAL ELECTRIC), 5 T ACHIEVA MRI (PHILIPS), WORKMATE CLARIS (ABBOTT) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WERE 6 MAJOR PROCEDURAL COMPLICATIONS INCLUDING: QTY 4: CARDIAC PERFORATIONS TREATED WITH PERICARDIAL DRAINS. QTY 1: AV FISTULA REQUIRING SURGICAL REPAIR. QTY 1: PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414895 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R 5 T ACHIEVA MRI (PHILIPS)| CARTO| SIGNA EXCITE CV/I (GENERAL ELECTRIC)| WORKMATE CLARIS (ABBOTT)