BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19515637 · Received June 11, 2024

    Report

    Report Number
    2029046-2024-01909
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 10-JUNE-2024. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL. BEFORE THE SURGERY, WHITE UNKNOWN FOREIGN MATERIAL WAS FOUND IN THE HEMOSTASIS VALVE OF THE DEVICE WHEN THE INNER PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. DEVICE WAS NOT USED IN PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE FOREIGN MATERIAL WAS DESCRIBED AS WHITE, AROUND 5MM AND IRREGULAR. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 17-JUN-2024, THE HEMOSTATIC VALVE WAS DISLODGED AND BROKEN IN THE STAR SECTION, THE SHAFT WAS BENT AND STRESS MARKS WERE OBSERVED ON THE DILATOR. THE RETURNED CONDITION OF THE HEMOSTATIC VALVE DISLODGED AND BROKEN IN THE STAR SECTION ON 17-JUN-2024 HAS BEEN ASSESSED AS REPORTABLE. THE AWARENESS DATE OF THIS REPORTABLE LAB FINDING IS 17-JUN-2024. THE INVESTIGATION WAS COMPLETED ON 17-JUN-2024. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE PHOTO DOES NOT PROVIDE SUFFICIENT INFORMATION RELATED TO THE REPORTED ISSUE BY THE CUSTOMER AND THEREFORE, NO RESULTS CAN BE OBTAINED FROM IT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BASED ON THE PICTURE RECEIVED. 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 DISLODGED AND BROKEN IN THE STAR SECTION, THE SHAFT WAS BENT AND STRESS MARKS WERE OBSERVED ON THE DILATOR. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE DAMAGE. THE BROKEN CONDITION OF THE HEMOSTATIC VALVE AND DILATOR AND SHAFT BENT 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. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE FOREIGN MATERIAL ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED SINCE THE HEMOSTATIC VALVE WAS ON THE IRRIGATION HUB. THE POTENTIAL CAUSE OF THE STRESS MARKS OF THE HEMOSTATIC VALVE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: 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; DO NOT REMOVE DILATOR OR CATHETER RAPIDLY. DAMAGE TO HEMOSTATIC VALVE MAY OCCUR. FROM THE SIDEPORT ONLY, ASPIRATE ALL AIR PRIOR TO FLUID INFUSION; BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE (C22)/INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE PHOTO PROVIDED. INVESTIGATION FINDINGS: FRACTURE PROBLEM (C070603)/INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)/COMPONENT CODE: VALVE(S) (G04135) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED "HEMOSTATIC VALVE WAS DISLODGED AND BROKEN IN THE STAR SECTION" ISSUE. IN ADDITION, THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE "HEMOSTATIC VALVE WAS DISLODGED AND BROKEN IN THE STAR SECTION". INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07)/INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)/COMPONENT CODE: ROD/SHAFT (G04112) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿THE SHAFT WAS BENT". INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706)/INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)/COMPONENT CODE: ROD/SHAFT (G04112) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE "STRESS MARKS WERE OBSERVED ON THE DILATOR". 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 (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL. BEFORE THE SURGERY, WHITE UNKNOWN FOREIGN MATERIAL WAS FOUND IN THE HEMOSTASIS VALVE OF THE DEVICE (PROVIDED PHOTO) WHEN THE INNER PACKAGE WAS JUST OPENED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. DEVICE WAS NOT USED IN PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 17-MAY-2024. THE PACKAGING AND THE CATHETER ALL HAVE BEEN RETURNED. THE FOREIGN MATERIAL WAS DESCRIBED AS WHITE, AROUND 5MM AND IRREGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197518 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000259 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown