BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 11644900 · Received April 9, 2021

    Report

    Report Number
    2029046-2021-00520
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 31-AUG-2021, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE MANUFACTURE DATE WAS 27-OCT-2020 AND THE EXPIRATION DATE WAS 27-OCT-2021. THOSE FIELDS WERE UPDATED ACCORDINGLY WITHIN THIS SUPPLEMENTAL REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6)2021, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE COMPLAINT DEVICE'S LOT NUMBER IS NOT 00001491 AS PREVIOUSLY INDICATED WITHIN THE INITIAL REPORT. CORRECTION: THE COMPLAINT DEVICE'S LOT NUMBER IS 00001419. THE LOT NUMBER HAS BEEN UPDATED ACCORDINGLY IN SECTION D4 OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER:(B)(4)

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 0001491 NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM. AIR WAS FOUND IN THE HEMOSTATIC VALVE OF VIZIGO, BUT IT WAS TEMPORARY. ALTHOUGH VIZIGO WAS DIFFICULT, THE PROCEDURE WAS COMPLETED WITHOUT REPLACING IT BECAUSE THE AIR CONSTRICTED (RESOLVED). THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. AIR-FLOW INTO THE SIDE PORT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541490 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001419 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTARAY ECO NAV| SMARTABLATE IRRIGATION TUBING