BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 16550059 · Received March 15, 2023

    Report

    Report Number
    3014687026-2023-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 23, 2023
    Report Date
    May 1, 2023
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786445
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HARDWARE ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BALLOON SEPARATED AT THE RX PORT. THE REPORTED FAILURE MODE WAS CONSISTENT WITH A KNOWN DEVICE ISSUE.

    Description of Event or Problem · 0

    THE BALLOON WAS USED IN THE PROXIMAL POPLITEAL - SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A PASS, THE BALLOON WAS DEFLATED. UPON REMOVAL, THE SURGEON NOTICED THE BALLOON CATHETER WAS OUTSIDE THE SHEATH. THE BALLOON CATHETER REPORTEDLY BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BALLOON IN THE DISTAL RAPID EXCHANGE PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A SECOND BALLOON. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE EVENT PERTAINED TO A RADIAL PROCEDURE. DURING REMOVAL, THE SURGICAL TECHNICIAN CONFIRMED THE BALLOON WAS DEFLATED. NO RESISTANCE WAS MET. ONCE REMOVED FROM THE SHEATH, THE DISTAL SEGMENT REMAINED IN THE PATIENT. THE CATHETER SEPARATED AT THE RX PORT. IMAGING CONFIRMED THE BALLOON MARKER BANDS WERE OUTSIDE OF THE SHEATH. THE SURGEON WAS ABLE TO USE A SNARE AND RETRIEVE THE CATHETER SEGMENT WITHIN APPROXIMATELY FOUR MINUTES. NO ADDITIONAL INTERVENTIONS OR ACCESS POINTS WERE REQUIRED. THE ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY FOUR MINUTES. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    THE BALLOON WAS USED IN THE PROXIMAL POPLITEAL - SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A PASS, THE BALLOON WAS DEFLATED. UPON REMOVAL, THE SURGEON NOTICED THE BALLOON CATHETER WAS OUTSIDE THE SHEATH. THE BALLOON CATHETER REPORTEDLY BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BALLOON IN THE DISTAL RAPID EXCHANGE PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A SECOND BALLOON. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE EVENT PERTAINED TO A RADIAL PROCEDURE. DURING REMOVAL, THE SURGICAL TECHNICIAN CONFIRMED THE BALLOON WAS DEFLATED. NO RESISTANCE WAS MET. ONCE REMOVED FROM THE SHEATH, THE DISTAL SEGMENT REMAINED IN THE PATIENT. THE CATHETER SEPARATED AT THE RX PORT. IMAGING CONFIRMED THE BALLOON MARKER BANDS WERE OUTSIDE OF THE SHEATH. THE SURGEON WAS ABLE TO USE A SNARE AND RETRIEVE THE CATHETER SEGMENT WITHIN APPROXIMATELY FOUR MINUTES. NO ADDITIONAL INTERVENTIONS OR ACCESS POINTS WERE REQUIRED. THE ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY FOUR MINUTES. THE TARGET VESSEL CONDITION WAS NOTED TO BE VERY DISEASED WITH MIXED THROMBUS MORPHOLOGY. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767960 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CREAGH MEDICAL SRA-DC18-60150 22200387 05391525786445

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female