BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME RADIAL ACCESS GUIDE SHEATH

    MDR report key: 13981065 · Received April 1, 2022

    Report

    Report Number
    3014687026-2022-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 25, 2022
    Manufacturer
    CREAGH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K190644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HUB CAP ON THE PROXIMAL HUB OF SHEATH BECAME DETACHED DURING HIGH PRESSURE INJECTIONS. THE PHYSICIAN APPLIED 600 PSI PRESSURE INJECTION USING POWER INJECTOR (OFF LABEL USE) CAUSING THE CAP ON THE PROXIMAL HUB TO BECOME DETACHED. THE PHYSICIAN INDICATED HE WAS ABLE TO PUT HIS THUMB OVER THE SHEATH AND WAS ABLE TO CONTINUE THE PROCEDURE WITH A SMALL AMOUNT OF LEAKAGE, NO ADVERSE EVENT OR OUTCOMES OBSERVED.

    Description of Event or Problem · 0

    SURMODICS' CUSTOMER SERVICE RECEIVED CALL FROM SALES REPRESENTATIVE. SALES REPRESENTATIVE REPORTS HE WAS PRESENT DURING CASE ON (B)(6) 2022 WHEN GUIDE SHEATH HUB CAME LOOSE FROM THE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN CROSSED THE LEGION (LEFT RADIAL) AND WHEN AN ATTEMPT WAS MADE TO DO A 600 PSI INJECTION, USING POWER INJECTION, THE HUB CAP CAME OFF AT THE VERY DISTAL END THAT SNAPS IN PLACE. USING POWER INJECTION IS INDICATED UNDER THE PRECAUTIONS SECTION OF THE SUBLIME GUIDE SHEATH IFU, DESCRIBING EXCESSIVE LEAKAGE AS A POSSIBLE OUTCOME. (B)(4). THE PHYSICIAN WAS ABLE TO HOLD HIS THUMB ON THE SHEATH AND WAS ABLE TO CONTINUE WITH THE PROCEDURE WITH SMALL AMOUNT OF LEAKAGE AND NO ADVERSE EVENTS OR OTHER PATIENT INJURY WAS OBSERVED.

    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
    1837967 SUBLIME RADIAL ACCESS GUIDE SHEATH INTRODUCER, CATHETER DYB CREAGH MEDICAL SRA-GS35-6F120 22100175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown