BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER

    MDR report key: 19280215 · Received May 9, 2024

    Report

    Report Number
    3005994106-2024-00005
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 9, 2024
    Report Date
    May 9, 2024
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525783666
    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

    H3: ANALYSIS OF THE RETURNED BALLOON CATHETER CONFIRMED THE REPORTED ISSUE. ONLY THE PROXIMAL SEGMENT WAS RETURNED. THERE WAS A DUCTILE FAILURE AT THE MID-SHAFT BOND OF THE DISTAL SUBASSEMBLY AND THE PROXIMAL JACKET. THE CAUSE OF THE FRACTURE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE SITE REPORTED HIGH VESSEL CALCIFICATION, BUT DID NOT REPORT ANY RESISTANCE DURING INSERTIONAL/REMOVAL.

    Description of Event or Problem · 0

    THE BALLOON CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE WITH LEFT COMMON FEMORAL ARTERY (CFA) ACCESS. THE TARGET VESSEL WAS THE POSTERIOR TIBIAL ARTERY. THE BALLOON CATHETER WAS USED TO FINISH THE PROCEDURE. IT WAS NOTED THE TARGET VESSEL WAS HIGHLY CALCIFIED. THERE WAS NO REPORT OF RESISTANCE BEING ENCOUNTERED DURING ADVANCEMENT/REMOVAL. THE PHYSICIAN WAS A HIGH VOLUME PROVIDER AND CONFIRMED DEFLATION PRIOR TO REMOVAL. DURING REMOVAL, THE CATHETER SHAFT SEPARATED IN THE MID TO DISTAL PORTION OF THE SHAFT. THE DISTAL SEGMENT COULD NOT BE RETRIEVED FOLLOWING SEVERAL HOURS OF EFFORT. DUE TO THE LENGTH OF THE CATHETER OUTSIDE OF THE PATIENT, THE REMAINING CATHETER WAS KEPT STRAIGHT OR IN LARGE LOOPS. THE PHYSICIAN STATED THE MIDSHAFT JOINT WAS RETAINED IN THE PATIENT POPLITEAL ARTERY DURING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AND PLACED ON HEPARIN OVERNIGHT. THE NEXT MORNING, AN ADDITIONAL OPEN AND CUT-DOWN PROCEDURE WAS PERFORMED TO SURGICALLY REMOVE THE DISTAL SEGMENT. THE BALLOON PORTION OF THE CATHETER WAS STILL CONNECTED TO THE SHAFT. NO FURTHER CATHETER SEGMENTS REMAINED. THERE WAS NO FURTHER PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358300 SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC14-20100 22201593 05391525783666

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention