BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14991511 · Received July 12, 2022

    Report

    Report Number
    2029046-2022-01589
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 23, 2022
    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

    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 4. 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

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 28-JUL-2022. THE DEVICE EVALUATION WAS COMPLETED ON 03-AUG-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND BLOOD WAS LEAKING FROM THE HEMOSTATIC VALVE. DEVICE EVALUATION DETAILS: 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 INSIDE OF HUB COMPONENT. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; 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 (DHR) WAS PERFORMED FOR THE FINISHED DEVICE 00001798 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) 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. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. 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

    H6. INVESTIGATION FINDINGS CODE OF "APPROPRIATE TERM/CODE NOT AVAILABLE" REPRESENTS PHOTO/VIDEO ANALYSIS. A VIDEO WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO THE VIDEO PROVIDED BY THE CUSTOMER, A BLOOD LEAKAGE WAS OBSERVED ON THE HUB SECTION. HOWEVER, DUE TO THE BLOOD ON THE HUB, IT IS NOT POSSIBLE TO SEE THE HEMOSTATIC VALVE. THE LEAKAGE OBSERVED ON THE DEVICE COULD BE RELATED TO A DISLODGMENT OF THE HEMOSTATIC VALVE INSIDE THE HUB, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE FINISHED DEVICE 00001798 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. BASED ON THE DHR, THE H 4. DEVICE MANUFACTURE DATE HAS BEEN UPDATED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE VIDEO RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND IS NOT POSSIBLE TO ASSIGN A ROOT CAUSE BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) 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. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW ON (B)(6)2022, IT WAS NOTED THAT THE H 10. ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE INITIAL 3500A REPORT WAS MISSING THIS STATEMENT: ¿THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, A VIDEO WAS PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS.¿

    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 ¿ SMALL AND BLOOD WAS LEAKING FROM THE HEMOSTATIC VALVE. DURING THE OPERATION, BLOOD LEAKAGE WAS FOUND IN THE HEMOSTATIC VALVE. THERE WAS NO PHYSICAL DAMAGE. THE HEMOSTATIC VALVE/BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT AND AIR DID NOT ENTER THE PATIENT¿S BODY. THE ISSUE DID NOT REQUIRE PERCUTANEOUS, SURGICAL REMOVAL OR MEDICAL INTERVENTION. BLOOD RETURN WAS OBSERVED. THE PATIENT HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING AND THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS BELOW 50ML. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700839 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001798 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BRAND SHEATH