BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP STENT¿

    MDR report key: 22663970 · Received July 30, 2025

    Report

    Report Number
    22663970
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 10, 2025
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    PNF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE COVERED PRE-MOUNTED STENT WOULD NOT FIT THROUGH THE 12F INTRODUCER. THE STENT COMES WITH 2 LOADERS (LITTLE BLUE STRAW), 12F AND 14F. IT DID NOT FIT INTO THE 12F ¿LOADER¿ (WHICH IT IS SUPPOSED TO) SO THE 14F WAS USED. THEN THE STENT WOULD NOT ADVANCE EASILY THROUGH THE 12F INTRODUCER (WHICH IS MADE FOR THESE STENTS). UNDER FLUOROSCOPY, THE TEAM NOTICED THE STENT HAD SLIPPED BACKWARD ON THE BALLOON. THE MD REMOVED THE INTRODUCER AND BALLOON TOGETHER, UPSIZED TO A 14F INTRODUCER, AND OPENED ANOTHER STENT THAT WORKED FINE. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR STENT, 3.4CM STENT LENGTH, MOUNTED COVERED CP STENT, 8 ZIGS, .013IN PLATINUM WIRE, 16MM (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549631 CP STENT¿ AORTIC STENT PNF B. BRAUN INTERVENTIONAL SYSTEMS, INC 614362 CMCP-4038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown