BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17078672 · Received June 7, 2023

    Report

    Report Number
    2029046-2023-01237
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (EU). AIR FLOWED BACK INTO THE SIDE PORT ISSUE OCCURRED. THE PATIENT SUFFERED AN AIR EMBOLISM. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 25-JUL-2023 AND PER THE EVALUATION COMPLETION ON 28-JUL-2023, THE VALVE WAS BROKEN IN THE STAR SECTION. THE VALVE BROKEN ON THE STAR SECTION WAS ALSO ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 28-JUL-2023. THE DEVICE EVALUATION WAS COMPLETED ON 28-JUL-2023. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, IRRIGATION, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC WAS FOUND CORRECTLY IN ITS PLACE. AN IRRIGATION TEST WAS PERFORMED, AND LEAKAGE WAS OBSERVED DURING THE ANALYSIS. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED THAT THE VALVE WAS BROKEN IN THE STAR SECTION AND STRESS MARKS ON THE DAMAGE WERE OBSERVED. THE BROKEN 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. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE OPTIMAL DEVICE PERFORMANCE GUIDE (ODP) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH'S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. 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: (B)(4).

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (EU). AIR FLOWED BACK INTO THE SIDE PORT ISSUE OCCURRED. THE PATIENT SUFFERED AN AIR EMBOLISM. IT WAS REPORTED THAT THE SHEATH DREW AIR AND AIR WENT INTO THE PATIENT¿S BODY. THE PATIENT HAD A SHORT AIR EMBOLISM. BUT THE PATIENT IS FINE AND AFTER CHANGING THE SHEATH THE PROCEDURE WAS FINISHED WITHOUT MORE COMPLICATIONS. THE PATIENT NOW HAS NO MORE PROBLEMS AND IS DOING WELL. THERE WASN¿T ANY CLINICAL OUTCOME EXPERIENCED BY THE PATIENT. THERE WAS NO INFECTION OR ANYTHING LIKE THAT. THE PATIENT WAS FINE AND THERE WERE NO MORE CONSEQUENCES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 2 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. A HEARTSPAN NEEDLE WAS USED. NO SERVICE NEEDED OR PERFORMED ON PUMP. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION. INTERVENTION PROVIDED WAS PRODUCT CHANGED. OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE AIR FLOWED BACK INTO THE SIDE PORT ISSUE WAS ASSESSED AS MDR REPORTABLE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE. SINCE THE EVENT WAS 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 WAS TO BE CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955928 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 50000260 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening NON BWI-HEARTSPAN NEEDLE| SMARTABLATE PUMP KIT-WW| UNKNOWN BRAND SHEATH