BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15831758 · Received November 20, 2022

    Report

    Report Number
    2029046-2022-02883
    Event Type
    Malfunction
    Date Received
    November 20, 2022
    Date of Event
    November 2, 2022
    Report Date
    March 10, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    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

    INITIAL REPORTER NAME AND ADDRESS: INITIAL REPORTER PHONE: (B)(6). 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 (B)(6)2022, THE BWI 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. ON (B)(6)2022, THE PHOTO ANALYSIS OF THIS DEVICE WAS COMPLETED. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE 4TH ELECTRODE WAS MOVED FROM ITS ORIGINAL PLACE NEXT TO THE 3RD ELECTRODE, ALSO, THE ELECTRODE WAS OBSERVED LIFTED AND WITH AN APPARENTLY SHARP EDGE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A WIRE WAS EXPOSED FOR THE 4TH ELECTRODE, AND A FOREIGN MATERIAL (LIKELY BIOLOGICAL MATERIAL) WAS OBSERVED ATTACHED TO AN ELECTRODE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 50000136 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND IS NOT POSSIBLE TO ASSIGN A ROOT CAUSE BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY. 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

    ON 15-FEB-2023, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. AFTER COMPLETION OF THE PROCEDURE, VIZIGO WAS CAUGHT WHEN IT WAS REMOVED FROM THE INGUINAL REGION OF THE PUNCTURE SITE, AND IT WAS DIFFICULT TO REMOVE. AS A RESULT, A HANGNAIL WAS FORMED ON THE ELECTRODE PART, AND THE ELECTRODE POSITION WAS DEVIATED. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED ELECTRODE #4 WAS FOUND LOOSE ON THE DEVICE, IN ADDITION, THIS ISSUE LEAVING SOME INTERNAL PARTS EXPOSED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 50000136 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THERE ARE SOME PRECAUTIONS ON THE USE OF THE VIZIGO SHEATH: PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, PRE-ASSEMBLE THE SHEATH, DILATOR, AND STYLET ON THE TABLE. ADVANCE THE NEEDLE THROUGH THE DILATOR AND CHECK FOR EXCESSIVE RESISTANCE AS THE TIP OF THE NEEDLE ADVANCES THROUGH THE CURVATURE OF THE SHEATH/DILATOR ASSEMBLY. ADDITIONAL INVESTIGATION WAS INITIATED TO ADDRESS THE ROOT CAUSE OF THE RING DETACHMENT ISSUE. 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 AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. AFTER COMPLETION OF THE PROCEDURE, VIZIGO WAS CAUGHT WHEN IT WAS REMOVED FROM THE INGUINAL REGION OF THE PUNCTURE SITE, AND IT WAS DIFFICULT TO REMOVE. AS A RESULT, A HANGNAIL WAS FORMED ON THE ELECTRODE PART, AND THE ELECTRODE POSITION WAS DEVIATED. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE 4TH ELECTRODE HAS COME OFF AND MOVED NEXT TO THE 3RD ELECTRODE. THE WIRE WAS EXPOSED WHERE THE 4TH ELECTRODE DETACHED PART. THE 4TH ELECTRODE THAT DETACHED WAS PARTIALLY DEFORMED. SOMETHING LIKE A BIOLOGICAL SUBSTANCE AND A SMALL FIBROUS SUBSTANCE WERE ATTACHED. RESISTANCE WITH SHEATH IS NOT MDR-REPORTABLE. ELECTRODE DAMAGED WITH SHARP ROUGH EDGES IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349222 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000136 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown