BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 16549971 · Received March 15, 2023

    Report

    Report Number
    3014687026-2023-00002
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 17, 2023
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786445
    PMA / PMN Number
    K211044
    Adverse Event
    Yes
    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 CATHETER SEPARATED AT THE RX PORT. THE REPORTED FAILURE MODE WAS CONSISTENT WITH A KNOWN DEVICE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THE TARGET VESSEL WAS APPROXIMATELY 5-6MM. REGARDING THE REPORT OF "STICKY BALLOON", THERE WAS NO RESTRICTION WHEN UNSHEATHING THE BALLOON PROTECTOR. IT WAS NOTED THAT FORCE WAS REQUIRED TO CROSS THE LESION.

    Description of Event or Problem · 0

    THE BALLOON WAS BEING USED IN A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE WITH RADIAL ACCESS. AFTER THE SECOND INFLATION/DEFLATION, THE BALLOON WAS ADVANCED DISTAL IN THE TARGET ARTERY FOR THE THIRD PASS. THE BALLOON WAS DEFLATED COMPLETELY AND WHEN PULLING BACK, THE BALLOON SHAFT SEPARATED IN THE VESSEL. THE BALLOON WAS PULLED LESS THAN APPROXIMATELY 1MM BEFORE THE ISSUE OCCURRED. THE DISTAL BALLOON/SHAFT SEGMENT WAS LEFT IN THE TARGET VESSEL AND THE PROXIMAL SEGMENT WAS REMOVED. THE SURGEON WAS ABLE TO RETRIEVE THE CATHETER SEGMENT IN THE VESSEL. TWO SECONDARY ACCESS SITES WERE REQUIRED TO SNARE THE SEPARATED SEGMENT. ANOTHER BALLOON WAS ALSO REQUIRED FOR TAMPONADE. IT WAS NOTED THE BALLOON WAS DEFLATED WITH AN ELECTRONIC DEFLATOR. FURTHERMORE, THE TARGET VESSEL WAS HIGHLY CALCIFIED. PRIOR TO THE PROCEDURE, THE SURGEON STATED THE BALLOON WAS "STICKY" WHEN REMOVING FROM PACKAGING. THE ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY THREE HOURS. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710953 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 71 YR Unknown Required Intervention