BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEISMIQ

    MDR report key: 25107654 · Received May 6, 2026

    Report

    Report Number
    2124215-2026-24688
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BOLT MEDICAL, INC.
    Product Code
    PPN
    UDI-DI
    00850056723039
    PMA / PMN Number
    K250225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON BURST AND BECAME DIFFICULT TO REMOVE. A SEISMIQ ATK CATHETER WAS SELECTED FOR USE IN A PAD (PERIPHERAL ARTERY DISEASE) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AND BECAME DIFFICULT TO REMOVE. THE WHOLE SYSTEM WAS TAKEN OUT WITH THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227507 SEISMIQ PERCUTANEOUS CATHETER, ULTRASOUND PPN BOLT MEDICAL, INC. FG-006915 0000110961 00850056723039

    Patients

    Seq Age Sex Outcome Treatment
    1