BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 16392120 · Received February 16, 2023

    Report

    Report Number
    3014687026-2023-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 16, 2023
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786445
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HARDWARE ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BALLOON SEPARATION OBSERVED WAS CONSISTENT WITH TRYING TO REMOVE A BALLOON THAT WAS NOT FULLY DEFLATED. DUE TO THE BALLOON BEING IN SEGMENTS, THE BALLOON COULD NOT BE TESTED FOR LEAK OR RUPTURE THROUGH INFLATION.

    Description of Event or Problem · 0

    DURING THE PROCEDURE WHEN THE SURGEON WAS FINISHED WITH BALLOONING, RESISTANCE WAS MET WHEN REMOVING THE BALLOON THROUGH THE GUIDE SHEATH. THE SURGEON FELT THE BALLOON BURST AND SAW UNDER FLUOROSCOPY THAT THE BALLOON HAD BURST IN THE SHEATH. THE SURGEON THEN USED ANOTHER BALLOON TO PLUG THE END OF THE SHEATH TO TRAP THE REMAINING PIECES OF THE BALLOON IN THE SHEATH. THE SURGEON THEN PULLED EVERYTHING OUT. THERE WAS NO IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE SURGICAL TECHNICIAN USED THE SAME TECHNIQUE WHEN DEFLATING THE BALLOON AS USUAL. FLUOROSCOPY WAS ALSO PERFORMED TO CONFIRM DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556383 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER PERIPHERAL ANGIOPLASTY BALLOON CATHETER LIT CREAGH MEDICAL SRA-DC18-60150 22200125 05391525786445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown