BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH

    MDR report key: 16015805 · Received December 20, 2022

    Report

    Report Number
    2029046-2022-03194
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 31, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2-JAN-2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO PHYSICAL DAMAGE ON THE HEMOSTATIC VALVE. AIR WAS NOT INTRODUCED INTO THE PATIENT. THE PHYSICIAN PERFORMED ASPIRATION TO ELIMINATE BUBBLES. NO MEDICAL INTERVENTION REQUIRED. PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. 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

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 30-JAN-2023, 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 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

    ON (B)(6)2 023, THE NAME OF THE ACTUAL USER IS UNKNOWN, HOWEVER, THE CONTACT INFORMATION OF THE HEAD OF CARDIOLOGY WAS PROVIDED AND HAS BEEN UPDATED IN SECTION E. INITIAL REPORTER. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI THEN CONDUCTED A VISUAL INSPECTION AND AN IRRIGATION TEST OF THE SIDE PORT. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED REDDISH MATERIAL IN THE HUB AREA. NO DAMAGE WERE OBSERVED ON THE DEVICE. THE RETURNED SAMPLE WAS CONNECTED TO A SYRINGE WITH WATER AND NO LEAKAGE WAS OBSERVED. THEN, THE IRRIGATION TEST OF THE SIDE PORT WAS PERFORMED, AND NO ISSUES WERE OBSERVED. THE ISSUE REPORTED BY THE COSTUMER COULD NOT BE REPLICATED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. E1. INITIAL REPORTER PHONE: (B)(6) 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 AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND AN AIR FLOWING BACK INTO THE PORT ISSUE OCCURRED. DURING ASPIRATION OF THE VIZIGO, THE HEMOSTATIC VALVE LET GO AIR INSIDE. THIS HAPPENED AFTER TRANSSEPTAL PUNCTURES. PROCEDURE COULD BE FINISHED WITH A NEW VIZIGO SHEATH. PROCEDURE COULD BE FINISHED NORMALLY. NO PATIENT CONSEQUENCES. THE AIR FLOWING BACK INTO THE PORT ISSUE WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2915241 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00002119 10846835016253

    Patients

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