BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19125388 · Received April 17, 2024

    Report

    Report Number
    2029046-2024-01271
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 20, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6. MEDICAL DEVICE PROBLEM CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (A27)¿ REPRESENTS "PATIENT EVENT-NON SERIOUS". 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THERE WAS AIR IN THE SHEATH. IN ADDITION, THE PATIENT EXPERIENCED AIR EMBOLISM BUT DID NOT REQUIRE MEDICAL INTERVENTION. THE DEVICE EVALUATION WAS COMPLETED ON 07-MAY-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, BACK PRESSURE TEST, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE DOES NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. A BACK PRESSURE TEST WAS PERFORMED, AND NO AIR ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THERE WAS NO LEAKAGE AND NO BUBBLES WERE DETECTED. NO AIR LEAKS WERE OBSERVED. THEREFORE, THE COMPLAINT WAS NOT DUPLICATED, AND IT COULD NOT BE CONFIRMED. THE AIR 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 INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE IFU: 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. 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 A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THERE WAS AIR IN THE SHEATH. IN ADDITION, THE PATIENT EXPERIENCED AIR EMBOLISM BUT DID NOT REQUIRE MEDICAL INTERVENTION. THE HUB ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS NOT AIRTIGHT. WHEN THE PHYSICIAN DREW BACK THE SYRINGE, THERE WAS AIR IN THE SHEATH. WHEN THE SHEATH WAS REPLACED, THE ISSUE RESOLVED. SEPARATELY IT WAS ALSO REPORTED THAT THE SMART TOUCH SF CATHETER WAS ROTATING AROUND THE TIP OF THE CARTO 3 SYSTEM WHEN IT WAS INSERTED INTO THE BODY. THE ICON WAS SPINNING ON THE SCREEN. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED. AIR WAS INTRODUCED INTO THE PATIENT. THE PHYSICIAN USED A SYRINGE TO PULL BACK AIR FROM THE SHEATH. NO MEDICAL INTERVENTION REQUIRED. NO NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE SPINNING ICON FOR THE CATHETER WAS A HIGHLY DETECTABLE ISSUE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE ADVERSE EVENT WAS ASSESSED AS A NON REPORTABLE PATIENT EVENT NON SERIOUS EVENT. THE AIR IN THE SHEATH ISSUE WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231565 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000338 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEARTSPAN NEEDLE| THMCL SMTCH SF BID, TC, D-F| UNK CABLE| UNK_CARTO 3