BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL

    MDR report key: 8923416 · Received August 22, 2019

    Report

    Report Number
    2029046-2019-03568
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    January 27, 2019
    Report Date
    February 1, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON(B)(6)2019 , BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE PRINCIPLE INVESTIGATOR ASSESSED THE PATIENT ADVERSE EVENT (RIGHT GROIN HEMATOMA) AS NOT RELATED TO THE INDEX PROCEDURE. BASED ON THIS NEW INFORMATION, THE COMPLAINT HAS BEEN REASSESSED AND THIS EVENT IS NO LONGER CONSIDERED TO BE MDR REPORTABLE. HOWEVER, SINCE THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, BIOSENSE WEBSTER INC. WILL CONTINUE TO REPORT SUPPLEMENTAL MDRS TO FDA AS ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT. MANUFACTURER¿S REF # PC-000384666.

    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 MANUFACTURE RECORD EVALUATION (MRE) COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER.  (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC. (BWI), IT WAS REPORTED THAT A 54-YEAR-OLD MALE PATIENT (177.80 CM, 110.6 KG) UNDERWENT A CARDIAC ABLATION PROCEDURE ON (B)(6) 2019 WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL. DURING THE PROCEDURE, ABLATION WAS PERFORMED WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND 98 RADIOFREQUENCY (RF) APPLICATIONS WERE DELIVERED. NO DEVICE DEFICIENCIES WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCES. ON POST-PROCEDURE DAY 3 (1/27/2019), THE PATIENT DEVELOPED RIGHT GROIN HEMATOMA. NI DUPLEX SCAN WAS TAKEN IN THE RIGHT LEG ARTERY FOR GROIN EXPLORATION. THE HEMATOMA HAD TO BE SURGICALLY REMOVED. EXTENDED HOSPITALIZATION (4 DAYS) WAS REQUIRED. ISSUE WAS RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, NOT RELATED TO THE STUDY DEVICE (VISITAG SURPOINT EPU), NOT RELATED TO THE STUDY CATHETERS AND NOT RELATED TO BWI NON-INVESTIGATIONAL DEVICES, AND ASSESSED A CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THIS EVENT WAS EXPECTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713462 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC. 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R CARTO 3 SYSTEM| CARTO3 EXTERNAL REFPATCH 6PACK| CBL, 34 HYP/34 LEMO, 10'| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, D-F| VISITAG SURPOINT EPU