BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8609920 · Received May 14, 2019

    Report

    Report Number
    2029046-2019-03144
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7/16/2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SEVERITY OF THE EVENT HAS BEEN ASSESSED AS MODERATE. IT WAS PREVIOUSLY ASSESSED AS MILD. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 5/23/2019, BIONSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE PRINCIPLE INVESTIGATOR UPDATED THE ADVERSE EVENT TERM OF "ASPIRATION PNEUMONIA A IN THE LUNG LEFT LOBE" TO "ASPIRATION" AND LOGGED "LEFT LOBE INFILTRATE" AS A SEPARATE ADVERSE EVENT. CORRECTION: ON 6/17/2019, IT WAS IDENTIFIED THAT INCORRECT INFORMATION WAS REPORTED IN THE INITIAL MDR. IT WAS REPORTED THAT NO PRODUCT HAD BEEN RETURNED AT THE TIME OF SUBMITTING THE INITIAL 3500A. HOWEVER, IT SHOULD HAVE BEEN REPORTED THAT THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS SUCH, THE METHOD CODE HAS BEEN CORRECTED FROM 4114 (DEVICE NOT RETURNED) TO 4115 (DEVICE DISCARDED). ADDITIONALLY, ON 6/17/2019, IT WAS NOTICED THAT THE FOLLOWING CONCOMITANT PRODUCTS WERE INADVERTENTLY OMITTED FROM THE INITIAL MDR: CONCOMITANT BWI PRODUCTS - SMARTABLATE RF GENERATOR (US CATALOG # M490007, SERIAL # (B)(4)); THERMOCOOL SMARTTOUCHSF/ST INTERFACE CABLE (US CATALOG # CR3434CT, LOT # UNKNOWN); CARTO 3 V6.0 SYSTEM (US CATALOG # UNKNOWN, SERIAL # LOT); CARTO EXTERNAL REFERENCE PATCHES (US CATALOG # CREFP6, LOT # UNKNOWN); SMARTABLATE IRRIGATION PUMP (US CATALOG # UNKNOWN, SERIAL # LOT). MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    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. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30133158L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. CONCOMITANT MEDICAL PRODUCTS: VISITAG SURPOINT EPU (US CATALOG # D160801, LOT #30103136L). MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER INC. (BWI), IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED ASPIRATION PNEUMONIA REQUIRING MEDICATION. ON POST-PROCEDURE DAY 1, THE PATIENT DEVELOPED ASPIRATION PNEUMONIA IN THE LUNG LEFT LOBE. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, UNRELATED TO THE STUDY DEVICE (VISITAG SURPOINT), UNRELATED TO THE STUDY CATHETERS, UNRELATED TO THE BWI NO-INVESTIGATIONAL DEVICES AND CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400051 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30133158L 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R