BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15460490 · Received September 21, 2022

    Report

    Report Number
    2029046-2022-02280
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    September 1, 2022
    Report Date
    December 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    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

    ON 18-OCT-2022, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE STRESS MARKS SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED DUE TO AN EXTREME OFF-AXIS ANGLE OF INSERTION. VALVE DISLODGEMENT OCCURS WHEN EXTREME OFF-AXIS ANGLES ARE PERFORMED DURING INSERTION WITH THE DILATOR, OUTSIDE OF WHAT IS RECOMMENDED IN THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 50000150 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 0

    ON 30-NOV-2022, THE PHOTO ANALYSIS WAS COMPLETED. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. THIS ISSUE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 50000150 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE PICTURE RECEIVED. PLEASE REFER TO THE PHYSICAL ANALYSIS OF THE DEVICE FOR MORE DETAILS. 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. 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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED A PICTURE OF THE COMPLAINT DEVICE FOR EVALUATION BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. THIS ISSUE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 50000150 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE PICTURE 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. 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 AN UNKNOWN PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. THE VALVE WAS DISLODGED IN THE HUB CAUSING LEAKING. IT WAS REPORTED THAT DURING THE OPERATION, BLOOD LEAKAGE WAS FOUND IN HEMOSTATIC VALVE. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORT. ATTACHED PHOTO NOTED TO HAVE VALVE IN THE HUB. THE BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. AIR DID NOT ENTER THE PATIENT¿S BODY. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 50ML. HEMOSTATIC VALVE SEPARATION IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776595 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000150 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown