BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM

    MDR report key: 11665595 · Received April 14, 2021

    Report

    Report Number
    2029046-2021-00574
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2021. THE CLEAR HUB WAS THE SECTION BROKE/SEPARATE. THE HUB DID BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON A PATIENT AND AIR DID NOT ENTER THE PATIENT¿S BODY. THE ISSUE DID NOT REQUIRE PERCUTANEOUS, SURGICAL REMOVAL OR MEDICAL INTERVENTION. THE PATIENT HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS UNKNOWN. INITIALLY IT WAS REPORTED THAT THE HUB WAS DETACHED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED ON(B)(6)2021 THAT THE HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE THE HUB OF THE DEVICE. THE HEMOSTATIC VALVE SEPARATION ISSUE IS ASSESSED AS A MDR REPORTABLE ISSUE. THEREFORE, ADDED "MATERIAL SEPARATION" IN H6. MEDICAL DEVICE PROBLEM CODE. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA WOLFF-PARKINSON-WHITE (WPW) SYNDROME (AVNRT/WPW) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A HUB DETACHMENT ISSUE OCCURRED. THE HUB OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM BROKE OFF DURING THE TRANSSEPTAL PUNCTURE. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2021. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI THEN CONDUCTED VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE OF HUB OF THE VIZIGO SHEATH. MICROSCOPIC EXAMINATION IN THE HEMOSTATIC VALVE SURFACE HAS SHOWN EVIDENCE OF STRESS MARKS ON THE OUTER DIAMETER. IN THE OTHER HAND, THE BRIM CAP AND THE SILICONE RING WERE PLACED IN THE CORRECT POSITION AND FOUND IN GOOD CONDITIONS. A DEVICE HISTORY RECORD WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE THE CONDITIONS OBSERVED IN THE HEMOSTATIC VALVE. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT HEMOSTATIC VALVE WAS FOUND DISLODGED INTO THE HUB. IT WAS DETERMINED THAT THE ISSUE 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 WHICH SUGGEST THAT EXCESSIVE FORCE WAS APPLIED. ACCORDING TO THE ODP (OPTIMAL PERFORMANCE GUIDE), THERE ARE SOME PRECAUTIONS ON INSERTING THE DILATOR INTO THE VIZIGO SHEATH: ¿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 THE DEVICE FOR EVALUATION ON 4/14/2021. 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. 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 A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA WOLFF-PARKINSON-WHITE (WPW) SYNDROME (AVNRT/WPW) ABLATION PROCEDURE WITH A CARTO VIZIGO" 8.5F BI-DIRECTIONAL GUIDING SHEATH  MEDIUM AND A HUB DETACHMENT ISSUE OCCURRED. THE HUB OF THE CARTO VIZIGO" 8.5F BI-DIRECTIONAL GUIDING SHEATH  MEDIUM BROKE OFF DURING THE TRANSSEPTAL PUNCTURE. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS A MDR REPORTABLE HUB DETACHMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565798 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001554 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BRAND SHEATH