BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19066315 · Received April 8, 2024

    Report

    Report Number
    2029046-2024-01160
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(4). 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 21-MAY-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE PHYSICIAN IDENTIFIED A VALVE ISSUE. THE PHYSICIAN WAS UNSURE IF AIR ENTERED THE VALVE. THERE WERE NO FRAGMENTS GENERATED. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS BROKEN CLOSE TO THE STAR SECTION, ADDITIONALLY, THE PORT TUBING WAS FOUND BROKEN AND SEPARATED FROM THE HUB. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE BREAKAGE AREA. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 60000319 AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE HEMOSTATIC VALVE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE BROKEN VALVE CONDITION COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH; THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE SIDE PORT TUBING BROKEN CONDITION COULD BE RELATED TO THE HANDLING OF THE DEVICE AFTER THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE. AFTER THE SHEATH IS IN THE LEFT ATRIUM OF THE PATIENT, MAINTAIN A CONSTANT FLOW OF HEPARINIZED NORMAL SALINE TO THE SHEATH TO MINIMIZE THE RISK OF AIR EMBOLI. 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. ONCE THE SHEATH IS INSERTED INTO THE VASCULATURE AND THE DILATOR IS REMOVED, ASPIRATE UNTIL STEADY BLOOD RETURN IS ACHIEVED PRIOR TO FLUSHING OR INFUSION. ALL FLUID INFUSION SHOULD BE THROUGH THE SIDE PORT. IN ORDER TO MINIMIZE THE RISK OF AIR EMBOLISM PROVIDE A CONTINUOUS INFUSION OF HEPARINIZED SALINE SOLUTION ONCE THE SHEATH IS INSERTED INTO THE PATIENT. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-001563413

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE PHYSICIAN IDENTIFIED A VALVE ISSUE. THE PHYSICIAN WAS UNSURE IF AIR ENTERED THE VALVE. THERE WERE NO FRAGMENTS GENERATED. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. A FOLLOW-UP WAS ATTEMPTED FOR ADDITIONAL INFORMATION BUT NO DETAILS HAVE BEEN PROVIDED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427885 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000319 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown