BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM

    MDR report key: 10522220 · Received September 11, 2020

    Report

    Report Number
    2029046-2020-01226
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/17/2020, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THE BRIM CAP DETACHMENT OCCURRED. IT WAS REPORTED THAT AT THE HUB BROKE OFF THE BASE OF THE OF SHEATH WHEN THE PHYSICIAN WAS ADVANCING A CATHETER. IT DETACHED AND SEPARATED. MINIMAL BLOOD WAS OBSERVED; NOT AFFECTING HEMODYNAMICS AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. AIR DID NOT ENTER THE PATIENT¿S BODY. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. DEVICE EVALUATION DETAILS: THE BRIM CAP WAS DETACHED FROM THE HUB. NO OTHER DAMAGES OBSERVED IN THE BRIM CAP. HEMOSTATIC VALVE AND FRICTION RING REMAINED INTACT. SMALL TRACES OF GLUE RESIDUES WERE FOUND ON BRIM CAP AND THIS IS EVIDENCE THAT THE DEVICE WAS PROPERLY MANUFACTURED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 00001347 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE BRIM CAP DETACHMENT FROM THE HUB COULD BE RELATED TO HANDLING OF THE DEVICE DURING THE PROCEDURE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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

    A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001347 NUMBER, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THE BRIM CAP DETACHMENT OCCURRED. IT WAS REPORTED THAT AT THE HUB BROKE OFF THE BASE OF THE OF SHEATH WHEN THE PHYSICIAN WAS ADVANCING A CATHETER. IT DETACHED AND SEPARATED. MINIMAL BLOOD WAS OBSERVED; NOT AFFECTING HEMODYNAMICS AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. AIR DID NOT ENTER THE PATIENT¿S BODY. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THIS EVENT IS BEING CODED AND REPORTED AS ¿BRIM CAP DETACHMENT¿ SINCE THERE IS NO INDICATION THAT THE PATIENT¿S HEMODYNAMICS WAS COMPROMISED, OR THAT ANY INTERVENTION WAS REQUIRED; THIS EVENT WILL NOT BE CODED AS PATIENT EVENT. ON 9/8/2020, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. ON 9/9/2020, THE COMPLAINT DEVICE WAS INSPECTED AND IT WAS FOUND THAT THE BRIM CAP WAS DETACHED FROM THE HUB. NO OTHER DAMAGES WERE OBSERVED TO THE BRIM CAP. THIS FINDING WAS REVIEWED AND DETERMINED IT CONTINUES TO BE DEEMED MDR REPORTABLE. ITS CONSISTENT WITH THE CUSTOMER¿S REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986332 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC. D138502 00001347 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 8.5F SHEATH WITH CURVE VIZ MDC| UNKNOWN CATHETER