BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16275576 · Received January 31, 2023

    Report

    Report Number
    2029046-2023-00192
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 6, 2023
    Report Date
    August 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
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2023. 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM HAD AIR TRAPPED IN THE HUB AND THEY WERE UNABLE TO CLEAR IT. UPON REPLACING THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM ALL ISSUES WERE RESOLVED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE EVALUATION WAS COMPLETED ON 13-JUL-2023. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE WAS CONNECTED TO THE WATER PUMP AND WATER LEAKAGE WAS OBSERVED DURING THE TEST ON THE HANDLE ZONE; HOWEVER, AIR IN THE HUB WAS NOT OBSERVED DURING THE TEST. A SUPPLIER INVESTIGATION WAS PERFORMED AND IT WAS CONCLUDED DUE TO THE CURRENT CONTROLS IN PLACE AND THE CONDITION OF THE RETURN, THIS COMPLAINT COULD NOT BE CONFIRMED TO BE MANUFACTURING ATTRIBUTABLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. 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. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19)/ INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿AIR TRAPPED IN THE HUB¿. -INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ROD/SHAFT (G04112) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿WATER LEAKAGE OBSERVED DURING THE TEST ON THE HANDLE ZONE¿. 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

    INITIALLY IN THE 3500A INITIAL A CONCOMITANT PRODUCT OF THMCL SMTCH SF BID, TC, F-J WAS REPORTED. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2023, UPDATING THIS PRODUCT TO THMCL SMTCH SF BID, TC, D-F. THEREFORE, UPDATED THE D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES FIELD. 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) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM AND AIR FLOWED BACK INTO THE SIDE PORT. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM HAD AIR TRAPPED IN THE HUB AND THEY WERE UNABLE TO CLEAR IT. UPON REPLACING THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM ALL ISSUES WERE RESOLVED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. AIR WAS NOT INTRODUCED INTO THE PATIENT. THE PHYSICIAN TRIED TO FLUSH THE SHEATH BUT WAS UNSUCCESSFUL. NO MEDICAL INTERVENTION REQUIRED. PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE LOT NUMBER OF THE DEVICE WAS UNAVAILABLE BECAUSE THE NURSES THREW AWAY THE PACKAGING AT THE BEGINNING OF THE PROCEDURE. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR AIR FLOWED BACK INTO THE SIDE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385006 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 60000036 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THMCL SMTCH SF BID, TC, D-F| THMCL SMTCH SF BID, TC, F-J| UNKNOWN BRAND CATHETER| UNK_CARTO 3