BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON CATHETER

    MDR report key: 24567453 · Received March 10, 2026

    Report

    Report Number
    MW5185047
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Report Date
    January 8, 2026
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED A BALLOON AND CATHETER WERE STUCK. THE SURGEON REQUESTED TO USE NEUROPROTECTION SYSTEM (NPS) FOR FLOW REVERSAL FOR A NON TCAR PROCEDURE (STENTING THE INNOMINATE.) HE USED SHOCKWAVE THROUGH THE NPS SHEATH. AFTER USING A NON-(B)(6) BALLOON OVER A V14 WIRE, HE COULD NOT REMOVE THE BALLOON. HE NOTED DIFFICULTY REMOVING THE WIRE AND BALLOON TOGETHER AND IT APPEARED STUCK IN THE SHEATH. HE PULLED THE BALLOON AND WIRE OUT IN ONE PIECE. THE NON-(B)(6) REP INSPECTED AND NOTED THAT THE BALLOON AND CATHETER HAD SEIZED OVER THE WIRE CAUSING THEM TO BECOME ONE PIECE. WHEN THE SHEATH WAS REMOVED, THE SURGEON NOTED THE TIP OF THE SHEATH APPEARED TO BE MISSHAPEN. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615865 BALLOON CATHETER PERCUTANEOUS CATHETER, ULTRASOUND PPN SHOCKWAVE MEDICAL, INC. BALLOON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown