BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME RADIAL ACCESS 018 RXPTA DILATATION CATHETER

    MDR report key: 13980713 · Received April 1, 2022

    Report

    Report Number
    3014687026-2022-00003
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 14, 2022
    Manufacturer
    CREAGH MEDICAL
    Product Code
    LIT
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SURMODICS' SALES MANAGER (B)(6) WAS PRESENT DURING CASE ON 3/9 AT (B)(6) MEDICAL CENTER. SRA-DC18-6015 WAS USED ON PATIENT DURING THE CASE. WHILE REMOVING THE BALLOON OUT OF THE PATIENT'S BODY THE PHYSICIAN NOTICED THERE WAS A SHARP WIRE COMING OUT OF THE RX PORT. PROCEDURE WENT AS EXPECTED. NO PATIENT HARM CAUSED. DEVICE BEING RETURNED BY SALES MANAGER TO SURMODICS IN BIOHAZARD BAG.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT STATES "WHEN REMOVING THE BALLOON OUT OF THE PATIENTS BODY, THE PHYSICIAN NOTICED A SHARP WIRE COMING OUT OF THE RX PORT". THE MANUFACTURING BATCH HISTORY RECORD (BHR) AND BALLOON BHR WERE REVIEWED WITH NO ISSUES NOTED. THE DEVICE WAS RETURNED IN A WRAPPED STATE WITH MULTIPLE BENDS ON THE HYPOTUBE. THERE IS EVIDENCE OF OUTER NECKING DAMAGE. AN ATTEMPT WAS MADE TO LOAD A 0.018" GUIDEWIRE WITH NO SUCCESS. A 0.014" GUIDEWIRE WAS THEN USED BUT NO SUCCESS DUE TO NECKING ON THE DEVICE. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON WITH WATER AND A SYRINGE WITH ABOVE AVERAGE PRESSURE BUT THE BALLOON APPEARS TO BE FULLY INTACT. BASED ON THE EVALUATION, THE COMPLAINT IS CONFIRMED, BUT THE CAUSE IS INCONCLUSIVE.

    Description of Event or Problem · 0

    SURMODICS' SALES MANAGER, (B)(6), WAS PRESENT DURING CASE ON 3/9 AT (B)(6) MEDICAL CENTER. DEVICE, SRA-DC18-6015, WAS USED ON PATIENT DURING THE CASE. WHILE REMOVING THE BALLOON OUT OF THE PATIENT'S BODY THE PHYSICIAN NOTICED THERE WAS A SHARP WIRE COMING OUT OF THE RX PORT. PROCEDURE WENT AS EXPECTED. NO PATIENT HARM CAUSED. DEVICE BEING RETURNED BY SALES MANAGER TO SURMODICS IN BIOHAZARD BAG FOR EVALUATION.

    Description of Event or Problem · 0

    FOLLOW-UP REPORT TO SUBMIT ADDITIONAL INFORMATION NOT KNOWN AT TIME OF INITIAL SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824205 SUBLIME RADIAL ACCESS 018 RXPTA DILATATION CATHETER PTA CATHETER LIT CREAGH MEDICAL SRA-DC18-60150 22101971

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male