BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12981367 · Received December 10, 2021

    Report

    Report Number
    2029046-2021-02166
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 18, 2021
    Report Date
    January 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF.#: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND THERE WERE AIR BUBBLES IN THE HUB/VALVE OF THE VIZIGO SHEATH. IT WAS REPORTED THAT THEY HAD BUBBLES IN THE HUB/VALVE OF THE VIZIGO SHEATH THAT THEY COULD NOT CLEAR. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION AND AN EVALUATION OF THE BACKPRESSURE TEST OF THE VIZIGO SHEATH. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE VIZIGO SHEATH. PER THE EVENT, FLOW AND PRESSURE TESTS WERE PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES, AND NO ISSUES WERE OBSERVED. VALUES WERE OBSERVED WITHIN SPECIFICATIONS. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE. AFTER THE SHEATH IS IN THE LEFT ATRIUM OF THE PATIENT, MAINTAIN A CONSTANT FLOW OF HEPARINIZED NORMAL SALINE TO THE SHEATH TO MINIMIZE THE RISK OF AIR EMBOLI. FLUSH AND MAINTAIN CONTINUOUS SALINE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND THERE WERE AIR BUBBLES IN THE HUB/VALVE OF THE VIZIGO SHEATH. IT WAS REPORTED THAT THEY HAD BUBBLES IN THE HUB/VALVE OF THE VIZIGO SHEATH THAT THEY COULD NOT CLEAR. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PHYSICIAN NOTICED BUBBLES PRIOR TO ANY AIR BEING INTRODUCED TO PATIENT. PHYSICIAN THEN FLUSHED BUBBLES OUT OF SIDE PORTS. NO MEDICAL INTERVENTION HAS BEEN NEEDED OR NEUROLOGICAL SYMPTOMS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879033 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001581 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ SMC