BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16440688 · Received February 24, 2023

    Report

    Report Number
    2029046-2023-00389
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 30, 2023
    Report Date
    April 17, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. 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 AN ISSUE OF AIR BUBBLES IN THE SHEATH OCCURRED. IT WAS REPORTED, THAT THERE WAS AN AIR BUBBLE ON THE VIZIGO¿ SHEATH, AND COULD NOT BE CLEARED. TRIED TAKING THE SHEATH OUT AND FLUSHING IT BUT THE ISSUE WAS STILL THERE, THEY ALSO, TRIED TO COVER THE DILATOR AND ASPIRATE, BUT THE ISSUE CONTINUED. THE VIZIGO¿ SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED ON THE VIZIGO SHEATH. THE RETURNED SAMPLE WAS CONNECTED TO A SYRINGE WITH WATER AND NO LEAKAGE WAS OBSERVED. THEN THE FUNCTIONAL TEST OF THE SIDE PORT WAS PERFORMED, AND NO ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 27-FEB-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).

    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 AN ISSUE OF AIR BUBBLES IN THE SHEATH OCCURRED. IT WAS REPORTED, THAT THERE WAS AN AIR BUBBLE ON THE VIZIGO¿ SHEATH, AND COULD NOT BE CLEARED. TRIED TAKING THE SHEATH OUT AND FLUSHING IT BUT THE ISSUE WAS STILL THERE, THEY ALSO, TRIED TO COVER THE DILATOR AND ASPIRATE, BUT THE ISSUE CONTINUED. THE VIZIGO¿ SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. A REPLACEMENT VIZIGO¿ SHEATH WAS REQUESTED. AIR WAS NOT INTRODUCED INTO THE PATIENT. THE PHYSICIAN FLUSHED THE CATHETER TO ELIMINATE BUBBLES. THERE WAS NO PATIENT CONSEQUENCE AS SUCH, NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870461 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00002192 10846835016253

    Patients

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