BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM

    MDR report key: 10576843 · Received September 23, 2020

    Report

    Report Number
    2029046-2020-01307
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 10/1/2020, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. SHEATH WAS INSPECTED, AND VISUAL ANALYSIS REVEALED THAT HEMOSTATIC VALVE APPEARED DISLODGED INSIDE OF HUB. BRIM CAP AND FRICTION RING REMAIN INTACT. IT WAS DETERMINED THAT THE ISSUE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE HEMOSTATIC VALVE INSIDE THE HUB COULD BE RELATED WITH THE EXCESSIVE FORCE AND HANDLING OF THE SHEATH DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) PROVIDE ADDITIONAL INSTRUCTIONS ON HOW TO INSERT THE DILATOR INTO THE SHEATH. IN ADDITION, THERE IS EVIDENCE THAT THE SHEATH WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. 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 · 1

    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 · 1

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION, WHEN THE CATHETER WAS INSERTED WITHIN THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTO THE VEIN, A LEAK OF BLOOD (FEW DROPS) THROUGH THE SHEATH AT THE LEVEL OF THE HEMOSTATIC VALVE WAS OBSERVED. THE SHEATH WAS REPLACED, AND THE ISSUE RESOLVED. PATIENT¿S HEMODYNAMICS WAS NOT COMPROMISED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO STOP THE BLEEDING. NO AIR ENTERED TO THE PATIENT¿S BODY. SINCE THERE IS NO INDICATION OF HEMODYNAMICS DISRUPTION OR REQUIRED INTERVENTION, THIS PATIENT EVENT IS NOT MDR REPORTABLE. THE COMPLAINT IS MDR REPORTABLE AS THE HEMOSTATIC VALVE WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039485 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM INTRODUCER, CATHETER LYB BIOSENSE WEBSTER INC D138502 00001336 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1