BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12936901 · Received December 6, 2021

    Report

    Report Number
    2029046-2021-02121
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 6, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE NUMBER: PC-001016794 DURING AN INTERNAL REVIEW OF THIS EVENT ON 13-DEC-2021, IT WAS NOTICED THAT THIS EVENT SHOULD HAVE BEEN ASSESSED AS A ¿OBSTRUCTED SHEATH (OBSTRUCTION OF FLOW (A1409))¿ ISSUE AND NOT ¿INTRODUCER STUCK WITHIN THE SHEATH (FAILURE TO ADVANCE (A150204))¿. THE ISSUE OF ¿OBSTRUCTED SHEATH ¿ IS NOT CONSIDERED TO BE A MDR REPORTABLE ISSUE. THERE IS EVIDENCE OF A PRODUCT MALFUNCTION, AS THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION OR OTHERWISE PERFORMED AS INTENDED; HOWEVER, THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT WILL NO LONGER BE CONSIDERED MDR REPORTABLE. THE H6. MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM FAILURE TO ADVANCE (A150204) TO ¿OBSTRUCTION OF FLOW (A1409)¿.

    Additional Manufacturer Narrative · 0

    ON 06-DEC-2021, 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. BIOSENSE WEBSTER MANUFACTURER'S (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2021-02120 FOR PRODUCT CODE D138502 (CARTO VIZIGO¿¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM). (2) THIS REPORT FOR PRODUCT CODE D138502 (CARTO VIZIGO¿¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH TWO CARTO VIZIGO¿¿ 8.5F BI-DIRECTIONAL GUIDING SHEATHS ¿ MEDIUM AND AN ISSUE WITH THE DILATOR WAS ENCOUNTERED WHERE IT WAS NOT ABLE TO BE ADVANCED THROUGH THE SHEATH AND WOULD GET STUCK IN THE SHEATH. IT WAS REPORTED THAT UPON INSERTING THE DILATOR INTO THE VIZIGO¿ SHEATH, THE DILATOR WOULD NOT ADVANCE AND WOULD GET STUCK IN THE VIZIGO¿ SHEATH. THE VIZIGO¿ SHEATH WAS REPLACED WITH THE SAME LOT NUMBER VIZIGO¿ SHEATH WITHOUT RESOLUTION. THE REPLACEMENT VIZIGO¿ SHEATH HAD THE SAME ISSUE AS THE PREVIOUS VIZIGO¿ SHEATH. THE VIZIGO¿ SHEATH WAS REPLACED WITH A NON-BWI SHEATH (AGILIS) AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-NOV-2021. IT WAS REPORTED THAT THE RESISTANCE THEY WERE HAVING WITH THE SHEATH WAS WHEN THEY WERE TRYING TO PUT THE DILATOR INTO THE SHEATH. THERE WAS NO PHYSICAL DAMAGE ON SHEATH/DILATOR. THERE WAS NO OCCLUSION WHEN IRRIGATING THE SHEATH. THE SHEATH WAS PARTIALLY BLOCKED. THE DILATOR WAS NOT ABLE TO BE MOVED THROUGH THE SHEATH. THE DILATOR WAS STUCK ON THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836565 CARTO VIZIGO¿¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000023 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ MDC| NON-BWI SHEATH (AGILIS)