BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE SHEATH

    MDR report key: 22367862 · Received June 30, 2025

    Report

    Report Number
    3014687026-2025-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 30, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    DYB
    UDI-DI
    00812339030753
    PMA / PMN Number
    K231828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE POUNCE SHEATH WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. DESTRUCTIVE ANALYSIS FOUND A SEVERE KINK AT THE STRAIN RELIEF OF THE OUTER SHAFT. THE INNER SHAFT HAD A SEVERE FRACTURE AS THE SAME LOCATION AS THE OUTER SHAFT. SECTIONING OF THE INNER SHAFT FOUND MISSING BRAID WIRE NEAR THE KINK AND MOVED APPROXIMATELY 2 INCHES DISTALLY.

    Description of Event or Problem · 0

    THE POUNCE SHEATH WAS USED IN A LEFT AND RIGHT ILIAC VEIN AND INFERIOR VENA CAVA (IVC) THROMBECTOMY PROCEDURE. THE SHEATH WAS USED IN CONJUNCTION WITH THE 12FR ASPIRATION CATHETER. THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTED THE TIP OF THE CATHETER BECAME DAMAGED DURING THE PROCESS. THERE WAS NO REPORTED PATIENT HARM OR PROCEDURE DELAY. THE POUNCE SHEATH WAS INSERTED AT AN APPROXIMATE 45 DEGREE ANGLE. THE REPORTED ISSUE OCCURRED DURING THE INITIAL INSERTION OF THE ASPIRATION CATHETER. THE POUNCE SHEATH WAS NOT USED FOR MORE THAN ONE ACCESS SITE. THE REPORTED ISSUE DID NOT RESULT IN NEGATIVE CONSEQUENCES. THE SHEATH WAS EXCHANGED FOR A REGULAR 12F SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS A PROCEDURE DELAY OF APPROXIMATELY FIVE MINUTES. A PROVIDED PHOTO SHOWED INNER SHAFT BRAID WIRE AROUND THE ASPIRATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261519 POUNCE SHEATH PFS-0035-12F14 DYB SURMODICS, INC. PFS-0035-12F14 107888 00812339030753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female