BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17210547 · Received June 27, 2023

    Report

    Report Number
    2029046-2023-01392
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 5-AUG-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. ADDITIONALLY, BWI NOTED A CORRECTION TO THE 3500A INITIAL AS THE 1. MANUFACTURING SITE NAME WAS PROCESSED UNDER BIOSENSE WEBSTER INC (IRVINE) AND SHOULD HAVE BEEN PROCESSED AS FREUDENBERG MEDICAL LLC. CORRECTED G1. MANUFACTURING SITE NAME. IN ADDITION, CORRECTED G1. MANUFACTURER SITE ADDR. STREET LINE 1, G1. MANUFACTURER SITE CITY, G1. MANUFACTURER SITE STATE CODE AND G1. MANUFACTURER SITE ZIP CODE AND G1. MANUFACTURER SITE COUNTRY CODE. D4 LOT NUMBER HAS BEEN UPDATED TO 60000147. D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, BACK PRESSURE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SHAFT WAS BENT, NO OTHER DAMAGE WAS OBSERVED, THE HEMOSTATIC VALVE SURFACE DOES NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. A BACK PRESSURE TEST WAS PERFORMED, AND NO ISSUES WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000147 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO BUBBLES WERE DETECTED. THE AIR FLOWS BACK ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE POTENTIAL CAUSE OF THE BENT SHAFT COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING OR AFTER THE PROCEDURE, HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE IFU: USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE. MONITOR ANY POTENTIAL AIR ENTRAPPED AND COMPLETELY ASPIRATE ANY OBSERVED AIR OUT OF THE SIDE PORT; BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE; IF RESISTANCE IS ENCOUNTERED, DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE SHEATH 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 REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISVT - LEFT ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND MID-PROCEDURE THE HEMOSTATIC VALVE WAS ALLOWING AIRFLOW. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION: AIR WAS INTRODUCED INTO THE PATIENT; HOWEVER, NO PATIENT CONSEQUENCES OR NEUROLOGICAL SYMPTOMS WERE IDENTIFIED DURING THE PROCEDURE OR POST-PROCEDURE. AIR FLOW INTO SIDE PORT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540770 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 60000147 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown