BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER

    MDR report key: 18927266 · Received March 18, 2024

    Report

    Report Number
    3005994106-2024-00003
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 18, 2024
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525783888
    PMA / PMN Number
    K200700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED BALLOON CATHETER CONFIRMED A PUNCTURE JUST DISTAL TO THE PROXIMAL MARKER BAND. FLUID WAS ABLE TO BE PASSED THROUGH THE INNER LUMEN WITH THE USE OF AN INFLATION DEVICE AND OUT THE PUNCTURE LOCATION. NECKING WAS VISIBLE AT THE BALLOON AND CATHETER SHAFT BOND.

    Description of Event or Problem · 0

    THE BALLOON WAS USED DURING AN ATHERECTOMY PROCEDURE THROUGH THE LEFT RADIAL ARTERY. THE PHYSICIAN PERFORMED AND ANGIOGRAM WITH DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY USING A COMPETITOR'S LASER CATHETER TECHNOLOGY. UPON CONCLUSION OF THAT THERAPY, THE BALLOON WAS USED. THE BALLOON WAS DELIVERED TO THE TARGET LESION AND INFLATED WITHOUT ISSUE. DURING REMOVAL, THE BALLOON COULD NOT BE DEFLATED. SEVERAL TECHNIQUES WERE ATTEMPTED WITHOUT RESOLUTION. THE PHYSICIAN DECIDED TO USE A 21G NEEDLE TO POP THE BALLOON AND REMOVE. THE ISSUE OCCURRED AFTER THE INITIAL INFLATION THAT INTENDED TO BE INFLATED FOR APPROXIMATELY 30 SECONDS. THE BALLOON WAS INFLATED TO 6ATM. THE TORTUOSITY WAS REPORTED AS NORMAL. TROUBLESHOOTING INCLUDE MULTIPLE DEFLATION ATTEMPTS WITH THE INFLATOR, MANUAL PULL BACK WITH A SYRINGE ON SIDE, AND MANUAL PULL BACK DIRECT FROM THE BALLOON. THE PHYSICIAN ALSO INSERTED A GUIDEWIRE THROUGH THE BALLOON AND APPLYING MANUAL PRESSURE TO THE OUTSIDE OF THE PATIENT'S LEG TO POP. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 25 MINUTES. THERE WAS NO FURTHER PATIENT HARM. THERE WAS NO FURTHER PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556223 SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC14-35150 22201521 05391525783888

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention