BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVASC 6.0X44 MM

    MDR report key: 21963422 · Received May 5, 2025

    Report

    Report Number
    3014498720-2025-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 28, 2025
    Manufacturer
    VESALIO, INC.
    Product Code
    QEW
    UDI-DI
    00851279008514
    PMA / PMN Number
    K201085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PROACTIVE OUTREACH TO THE PHYSICIAN, (B)(6) WAS NOTIFIED THAT DURING SURGERY ON WEDNESDAY ((B)(6) 2025), THE PVASC 6.0X44 EXPANDABLE TIP DETACHED FROM THE PUSHER WIRE AND THE EXPANDABLE TIP COULD NOT BE REMOVED. THE PUSHER WIRE WAS REMOVED AND DISCARDED. UPON FOLLOW-UP, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PHYSICIAN: - THE PROCEDURE INVOLVED A CHRONIC ILIAC OCCLUSION. - A 2.7 HEADHUNTER WAS USED THOUGH A BOLT 6 TO DEPLOY THE PVASC DEVICE. - ONCE ENGAGED WITH THE CHRONIC CLOT, AN ATTEMPT WAS MADE TO WITHDRAW THE PVASC DEVICE INTO THE PENUMBRA BOLT 6 CATHETER BY A NON-PHYSICIAN WHILE THE PHYSICIAN WAS NOT SUPERVISING THEM. - THE PRODUCT DETACHED AND THE PHYSICIAN TACKED IT WITH A STENT. THE PHYSICIAN MENTIONED THAT HE PLANNED TO PLACE A STENT IN THE VESSEL ANYWAY. - THE PVASC WIRE WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103316 PVASC 6.0X44 MM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW VESALIO, INC. VP-6044-F3RR 101524B 00851279008514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention