BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 21702150 · Received March 26, 2025

    Report

    Report Number
    2029046-2025-00925
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 5, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT RETURNED FOR ANALYSIS; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE 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 REFERENCE NUMBER: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND AFTER PERFORMING THE POST-MAP, WHEN REMOVING THE OCTARAY FROM THE VIZIGO, A PLASTIC-LIKE PART GOT CAUGHT ON THE SPINE OF THE OCTARAY AND CAME OUT. THE PROCEDURE WAS TERMINATED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A DILATOR WAS INTRODUCED THROUGH THE SHEATH AND NO RESISTANCE WAS ENCOUNTERED. AFTERWARDS, A BORESCOPE INSPECTION OF THE INNER SHAFT WAS PERFORMED, AND NO DAMAGE WAS FOUND. IN ADDITION, THE TIP AND HUB SECTION WERE INSPECTED BUT NO ANOMALIES WERE FOUND. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, A COMPONENT WAS FOUND OUTSIDE THE SHEATH; HOWEVER, DURING THE PHYSICAL ANALYSIS, NO ANOMALIES WERE DETECTED. IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE MATERIAL OBSERVED, BASED ON THE PICTURE RECEIVED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 60000563, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE INTERNAL COMPONENTS EXPOSED 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 INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: USE FLUOROSCOPY AND/OR INTRACARDIAC ULTRASOUND TO MONITOR THE ADVANCEMENT OF THE CATHETER AND REMOVAL OF THE CATHETER FROM THE SHEATH. MOVE THE CATHETER CAREFULLY TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. IF RESISTANCE IS ENCOUNTERED, DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE SHEATH. AS PART OF THE JOHNSON & JOHNSON MEDTECH 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 A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AND AFTER PERFORMING THE POST-MAP, WHEN REMOVING THE OCTARAY FROM THE VIZIGO, A PLASTIC-LIKE PART GOT CAUGHT ON THE SPINE OF THE OCTARAY AND CAME OUT. THE PROCEDURE WAS TERMINATED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604937 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000563 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR.| OCTA,LNG,48P,3-3-3-3-3,D-CURVE.| QDOT MICRO, BI, TC, D-F.| SOUNDSTAR ECO SMS 8F CATHETER.