BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 20248145 · Received September 18, 2024

    Report

    Report Number
    3005994106-2024-00013
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 18, 2024
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    UDI-DI
    05391525786414
    PMA / PMN Number
    K211044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY ONE BALLOON SEGMENT WAS RETURNED. THIS SEGMENT INCLUDED THE CATHETER HUB TO RAPID EXCHANGE (RX) PORT. THE DISTAL PORTION OF THE RETURNED SECTION SHOWED OUTER CATHETER ELONGATION OF APPROXIMATELY 11CM PAST THE SKIVE.

    Description of Event or Problem · 0

    THE BALLOON CATHETER WAS USED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. RADIAL ANGIOPLASTY WAS PERFORMED IN ORDER TO AVOID AN OPEN PROCEDURE. THE SITE REPORTED THE BALLOON BURST AFTER INFLATION TO APPROXIMATELY 10 ATMS. THE PHYSICIAN WAS USING THE "KISSING BALLOON TECHNIQUE" FOR BIFURCATIONS. DURING REMOVAL, THE BALLOON CATHETER SHAFT SEPARATED FROM THE MAIN BODY NEAR THE RAPID EXCHANGE PORT DURING REMOVAL FROM A 6FR SHEATH. THE THOUGHT WAS THAT THE SITE DID NOT ALLOW FULL DEFLATION OF THE BALLOONS PRIOR TO PULLING BACK INTO THE SHEATH. THE PHYSICIAN HAD TO PERFORM A VESSEL CUTDOWN TO RETRIEVE THE SEPARATED SEGMENTS AND FINISH WITH ENDARTERECTOMY. THE SITE INDICATED THE BALLOONS SEPARATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. MULTIPLE ATTEMPTS AT DEFLATION WERE MADE. THE WIRE WAS NOT REMOVED. THE BALLOON SEPARATED APPROXIMATELY 10-20 CM FROM THE BALLOON MARKERBAND. THE FURTHER INTERVENTION OF ENDARTERECTOMY WAS REQUIRED FOR THE CALCIFIED ILIAC ARTERY AND BALLOON SEGMENT REMOVAL. BOTH BALLOON SEGMENTS WERE INTACT UPON REMOVAL. THE ENTIRE PROCEDURE LASTED APPROXIMATELY SEVEN HOURS WITH A FOUR HOUR DELAY DUE TO THE BALLOON SEPARATION AND CUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235585 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT CREAGH MEDICAL SRA-DC18-60080 22301040 05391525786414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention