BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9977318 · Received April 20, 2020

    Report

    Report Number
    2029046-2020-00567
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HEMOSTATIC VALVE SEPARATION ISSUE. DURING THE PROCEDURE, THE DILATOR COULD NOT BE ADVANCED THROUGH THE HUB OF THE SHEATH. THE INVESTIGATIONAL ANALYSIS COMPLETED 4/23/2020. THE DEVICE WAS INSPECTED AND HEMOSTATIC VALVE WAS PUSHED IN AND SHEATH WAS KINKED. DILATOR WAS NOT RETURNED. A SECOND CLOSER INSPECTION WAS PERFORMED AND BRIM CAP LOOKS INTACT AND HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE OF HUB AND SHEATH WAS KINKED. FRICTION RING AND BRIM CAP REMAIN INTACT. THE DISLODGED CONDITION NOTED ON THE HEMOSTATIC VALVE IS RELATED WITH THE CUSTOMER COMPLAINT AND MAY HAVE APPEARED TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING BEING APPLIED TO THE DEVICE. HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO NON-CONFORMANCE WAS FOUND DURING THE REVIEW. CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE HEMOSTATIC VALVE INSIDE THE HUB AND SHEATH KINKED COULD BE RELATED TO HANDLING OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HEMOSTATIC VALVE SEPARATION ISSUE. DURING THE PROCEDURE, THE DILATOR COULD NOT BE ADVANCED THROUGH THE HUB OF THE SHEATH. SHEATH REPLACEMENT RESOLVED THE ISSUE. THE CASE CONTINUED SUCCESSFULLY, AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED OBSTRUCTED SHEATH HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION ON 325/2020. UPON INITIAL INSPECTION, THE BWI PAL FOUND THE HEMOSTATIC VALVE DISLODGED INSIDE THE CLEAR HUB. THE OBSERVED HEMOSTATIC VALVE SEPARATION ISSUE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THE AWARENESS DATE HAS BEEN RESET TO 3/25/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443232 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER LPB BIOSENSE WEBSTER INC D138501 00001193 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1