BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16496211 · Received March 7, 2023

    Report

    Report Number
    2029046-2023-00478
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    January 1, 2023
    Report Date
    May 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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

    ON 25-APR-2023, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. THE PATIENT SUFFERED ARTERIAL SPASM. IT WAS REPORTED THAT THE SHEATH" WAS A BIT DIFFICULT TO MANIPULATE" TO REACH LEFT SUPERIOR PULMONARY VEIN (LSPV). AT THE END OF THE PROCEDURE, PATIENT EXPERIENCED VENOUS SPAMS ( IT WAS REPORTED IT ALREADY HAPPENED TO THE PATIENT DURING A PREVIOUS ABLATION, YEARS AGO). WHEN THE SHEATH WAS PULLED BACK, IT LOOKED LIKE A BIT TWISTED. THE OPERATOR DIDN¿T KNOW IF IT WAS BECAUSE OF MECHANICAL PROBLEM BEFORE THE PULL-BACK OR DURING THE PULL-BACK PHASE, BECAUSE OF THE VENOUS SPAMS. PROCEDURE WAS CARRIED OUT SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCE FOR THE PATIENT. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS REVEALED ELECTRODES #3 AND #4 OUT OF PLACE, BROKEN, WITH ROUGH EDGES AND WITHOUT POLYURETHANE (PU) ON THE EDGES; ADDITIONALLY, THE TIP OF THE DEVICE WAS A LITTLE DENTED, THIS CONDITION COULD BE RELATED TO THE TWISTED SHEATH ISSUE REPORTED BY THE CUSTOMER. PER THE EVENT, THE DIMENSIONAL, FUNCTIONALITY, AND ELECTRICAL FEATURES WERE TESTED. ISSUES WERE OBSERVED ON THE FUNCTIONALITY AND ELECTRICAL FEATURES DUE TO THE DAMAGE ELECTRODES AND TIP, NO OBSTRUCTION OR RESISTANCE WAS FELT. IN ADDITION, THE PRODUCT WAS DEFLECTING AND IRRIGATING CORRECTLY. THE ROOT CAUSE OF THE ELECTRODE'S DETACHMENT COULD BE RELATED TO THE SHEATH GETTING STUCK. NO ISSUES ON THE CATHETER WERE FOUND THAT COULD CONTRIBUTE TO THE ADVERSE EVENT. THE ROOT CAUSE OF THE STUCK ISSUE CANNOT BE DETERMINED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 00002069 AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE TWISTED SHEATH ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATION: 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 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 AN UNKNOWN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. THE PATIENT SUFFERED ARTERIAL SPASM. IT WAS REPORTED THAT THE SHEATH" WAS A BIT DIFFICULT TO MANIPULATE" TO REACH LEFT SUPERIOR PULMONARY VEIN (LSPV). AT THE END OF THE PROCEDURE, PATIENT EXPERIENCED VENOUS SPAMS ( IT WAS REPORTED IT ALREADY HAPPENED TO THE PATIENT DURING A PREVIOUS ABLATION, YEARS AGO). WHEN THE SHEATH WAS PULLED BACK, IT LOOKED LIKE A BIT TWISTED. THE OPERATOR DIDN¿T KNOW IF IT WAS BECAUSE OF MECHANICAL PROBLEM BEFORE THE PULL-BACK OR DURING THE PULL-BACK PHASE, BECAUSE OF THE VENOUS SPAMS. PROCEDURE WAS CARRIED OUT SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCE FOR THE PATIENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. BENT SHAFT IS NOT MDR-REPORTABLE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62893 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00002069 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening