BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIA-17 MICROCATHETER VIA-17-154-01

    MDR report key: 8972271 · Received September 6, 2019

    Report

    Report Number
    2032493-2019-00212
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    DQY
    UDI-DI
    00851566003710
    PMA / PMN Number
    K162565
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: (B1) ADVERSE EVENT, NOT PRODUCT PROBLEM CORRECTION: (B2) LIFE-THREATENING, NOT DISABILITY OR PERMANENT DAMAGE ADDITIONAL INFORMATION: (B5) (H10): IT IS UNKNOWN IF THE GUIDE WIRE OR THE MICROCATHETER CAUSED THE ANEURYSM RUPTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TREATMENT OF AN ACOM ANEURYSM WITH THE WEB SL DEVICE WAS PLANNED. DURING ACCESS OF THE ANEURYSM WITH A SYNCHRO GUIDEWIRE AND A VIA 17 MICROCATHETER, THE ANEURYSM WAS RUPTURED. THE WEB WAS IMMEDIATELY PLACED AND OPENED IN THE ANEURYSM. FOLLOW-UP DYNACT IMAGING DEMONSTRATED A LITTLE BLEEDING. THE PATIENT IS REPORTED TO BE "DOING FINE" AND IN GOOD CONDITION. THERE WAS NO REPORTED ADVERSE CLINICAL SEQUELA AS A RESULT OF THE RUPTURE.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ANEURYSM ACCESS WITH THE VIA 17 MICROCATHETER, THE PHYSICIAN RUPTURED THE ANEURYSM. SOME BLEEDING COULD BE OBSERVED ON DYNA-CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765786 VIA-17 MICROCATHETER VIA-17-154-01 MICROCATHETER DQY SEQUENT MEDICAL, INC FG17154-01 18101101 00851566003710

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| S