BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 17738534 · Received September 13, 2023

    Report

    Report Number
    3005994106-2023-00006
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 13, 2023
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786308
    PMA / PMN Number
    K211044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TO DATE, THE DEVICE HAD NOT BEEN RETURNED. IF RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED FOR ANALYSIS RESULTS.

    Description of Event or Problem · 0

    THE DEVICE WAS USED FOR BALLOON ANGIOPLASTY OF THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE APPROXIMATE VESSEL DIAMETER WAS 4MM WITH A LESION LENGTH OF APPROXIMATELY 150MM. THE ESTIMATED LESION CALCIFICATION WAS APPROXIMATELY 80%. THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DEVICE. REMOVAL WAS PERFORMED AFTER THE INITIAL PASS BY HOLDING NEGATIVE PRESSURE ON AN INFLATION DEVICE FOR APPROXIMATELY 5-10 SECONDS. DEFLATION WAS NOT CONFIRMED UNDER FLUOROSCOPY ONCE RESISTANCE WAS MET. THE PHYSICIAN "TUGGED PRETTY HARD" WHEN IT WAS NOTICED THE BALLOON WAS NOT MOVING UNDER FLUOROSCOPY DURING WITHDRAWAL. DURING THE REMOVAL PROCESS, THE SHAFT SEPARATED AT THE RAPID EXCHANGE (RX) PORT. THE INTRODUCER SHEATH NEEDED TO BE REMOVED WHEN THE BALLOON SEGMENT WAS SNARED BECAUSE THE BALLOON DID NOT DEFLATE ENOUGH TO PASS THROUGH THE SHEATH. ALL BALLOON SEGMENTS WERE RETRIEVED. AFTER REMOVAL, THE PHYSICIAN STILL NEEDED A 6MM BALLOON FOR THE PROXIMAL SFA SEGMENT. DUE TO REMOVING THE SHEATH, THE PHYSICIAN DECIDED TO GAIN FEMORAL ACCESS TO TREAT THE PROXIMAL SFA WITH A DRUG COATED BALLOON (DCB). THERE WAS NO FURTHER IMPACT TO PATIENT OUTCOME. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY ONE HOUR. THE REPORTED ISSUE MAY HAVE BEEN CAUSED BY A COMBINATION OF NOT FULLY DEFLATING THE BALLOON AND REMOVAL THROUGH HIGH CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789342 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-40220 22102633 05391525786308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention