BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22948023 · Received September 2, 2025

    Report

    Report Number
    2029046-2025-02942
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 9-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. PER INTERNAL REVIEW ON 30-SEP-2025, IT WAS IDENTIFIED THAT THE PRODUCT RECEIPT DATE (SECTION D10) OF THE INITIAL REPORT WAS MISTAKENLY OMITTED. THAT DETAIL HAS BEEN CORRECTED ON THIS REPORT. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND THE DEVICE WOULD NOT CROSS THE SEPTUM. AFTER MULTIPLE ATTEMPTS, THE TIP BECAME "BENT." THE SOFT TIP WAS NOT FOLDED OR WRINKLED ON ITSELF. NO DAMAGE WAS IDENTIFIED; HOWEVER, THE PHYSICIAN WAS UNCOMFORTABLE TRYING TO CROSS THE SEPTUM THE THIRD TIME HE CROSSED. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND DIMENSIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A DIMENSIONAL TEST WAS PERFORMED ON THE OUTER DIAMETERS OF THE SHAFT SHEATH, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. A MICROSCOPIC INSPECTION OF THE TIP WAS PERFORMED AND NO DAMAGE WAS FOUND. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 14925092 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE INTRACARDIAC RESISTANCE AND THE BENT TIP ISSUES REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE 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).

    Additional Manufacturer Narrative · 0

    PER INTERNAL REVIEW ON 11-SEP-2025, THE G SECTION PHYSICAL MANUFACTURER WAS UPDATED FROM FREUDENBERG MEDICAL LLC (INDIANA, USA ADDRESS) TO FREUDENBERG MEDICAL TO VISTAMED LTD IN IRELAND. G1 MANUFACTURING SITE POSTAL CODE N41N8C9. 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 ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND THE DEVICE WOULD NOT CROSS THE SEPTUM. AFTER MULTIPLE ATTEMPTS, THE TIP BECAME "BENT." THE SOFT TIP WAS NOT FOLDED OR WRINKLED ON ITSELF. NO DAMAGE WAS IDENTIFIED; HOWEVER, THE PHYSICIAN WAS UNCOMFORTABLE TRYING TO CROSS THE SEPTUM THE THIRD TIME HE CROSSED. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081078 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 14925092 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BAYLIS NRG RF TRANSEPTAL NEEDLE.| SOUNDSTAR ECO CATHETER.