BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER

    MDR report key: 20839680 · Received December 3, 2024

    Report

    Report Number
    3005994106-2024-00017
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 3, 2024
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525783673
    PMA / PMN Number
    K200700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE BALLOON CATHETER WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE BALLOON SEPARATION. THE DISTAL TIP OF THE BALLOON WAS NOT RETURNED.

    Description of Event or Problem · 0

    THE BALLOON CATHETER USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE OF A CALCIFIED TIBIAL ARTERY. THE BALLOON WAS INFLATED THREE TIMES. ON THE THIRD INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS INFLATED TO 8ATM, 4ATM, AND 6ATM RESPECTIVELY. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. IN DOING SO, THE DISTAL PORTION OF THE BALLOON SEPARATED AND WAS LEFT IN THE PATIENT'S ARTERY. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON SEGMENT, ALL OF WHICH WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO STENT THE ARTERY, ENSURING THE BALLOON SEGMENT WOULD NOT MIGRATE. THERE WAS NO FURTHER PATIENT HARM. THE PROCEDURE WAS DELAYED DUE TO THE UNSUCCESSFUL RETRIEVAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681264 SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC14-20150 22201239 05391525783673

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention