BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT 28FR DUAL LUMEN CATHETER

    MDR report key: 10557789 · Received September 19, 2020

    Report

    Report Number
    3011468686-2020-00006
    Event Type
    Injury
    Date Received
    September 19, 2020
    Date of Event
    August 21, 2020
    Report Date
    November 9, 2020
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    UDI-DI
    10854916006932
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MC3 RECIEVED PHOTOGRAPHIC EVIDENCE OF A CATHETER THAT WAS USED ON PATIENT FOR 53 DAYS. THE PHOTOGRAPH SHOWED A RADIAL FRACUTURE ON THE BODY OF THE CATHETER ON THE BLACK MARKER. THERSE WERE SEVERAL SUTUTRES IN MULTIPLE LOCATIONS WITH SOME PLACED ON THE CATHETER BODY. THE IFU WARNS " DO NOT SUTURE DIRECTLY AROUND THE WIRE-REINFORCED SECTION OF THE CATHETER AS IT CAN CUT, KINK, OR DAMAGE THE CATHETER. SUTURING ON THE CATHETER BODY SHOULD ONLY OCCUR ON THE INTEGRATED SUTURE SITE". THE FRACTURE MAY HAVE BEEN CAUSED BY THE SECUREMENT METHOD OR ANOTHER UNKNOWN REASON. THERE IS NO CLEAR EVIDENCE OF A KINK IN THE CATHETER FROM THE INFORMATION. THE RETURNED DEVICE WAS EXAMINED AND THE FRACTURE FOUND TO BE POSSIBLY CAUSED BY SUTURE SAW CUT OR SCAPEL CUT PROPAGATION.

    Description of Event or Problem · 0

    THE PATIENT WAS SUPPORTED ON ECMO SINCE APRIL 6 WITH EXTRACORPOREAL CIRCUIT INCLUDING SUBJECT CATHETER DEVICE FOR 53 DAYS. ON AUGUST 21, WHEN NURSES WERE TURNING PATIENT OVER AND RE-POSITIONING PATIENT , AIR STARTED ENTERING THE ECMO CIRCUIT. THE CLINICIANS COULD NOT FIND WHEREAIR WAS COMING FROM. THE CLINICIANS ATTEMPTED TO DE-AIR THE CIRCUIT, BUT AIR STILL ENTERED. PATIENT WAS TAKEN OFF ECMO SUPPORT AND THEN 40 MINUTES LATER THE PATIENT DIED, AFTERWORDS, THE CLINICIANS INSPECTED THE CATHETER AND FOUND A CRACK RIGHT ALONG ONE OF THE BLACK LINES BELOW GOLD SUTURE AREA. THIS WAS THE SUSPECTED LOCATION WHERE THE AIR ENTERED THE CIRCUIT.

    Additional Manufacturer Narrative · 1

    MC3 RECEIVED PHOTOGRAPHIC EVIDENCE OF A CATHETER THAT WAS USED ON PATIENT FOR 53 DAYS. THE PHOTOGRAPH SHOWED A RADIAL FRACTURE ON THE BODY OF THE CATHETER ON THE BLACK MARKER. THERE WERE SEVERAL SUTURES IN MULTIPLE LOCATIONS WITH SOME PLACED ON THE CATHETER BODY. THE IFU WARNS " DO NOT SUTURE DIRECTLY AROUND THE WIRE-REINFORCED SECTION OF THE CATHETER AS IT CAN CUT, KINK, OR DAMAGE THE CATHETER. SUTURING ON THE CATHETER BODY SHOULD ONLY OCCUR ON THE INTEGRATED SUTURE SITE". THE FRACTURE MAY HAVE BEEN CAUSED BY THE SECUREMENT METHOD OR ANOTHER UNKNOWN REASON. THERE IS NO CLEAR EVIDENCE OF A KINK IN THE CATHETER FROM THE INFORMATION. TT IS NOT POSSIBLE TO REACH A ROOT CAUSE WITHOUT INVESTIGATING THE SUBJECT DEVICE WHICH HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED ON ECMO SINCE (B)(6) WITH EXTRACORPOREAL CIRCUIT INCLUDING SUBJECT CATHETER DEVICE FOR 53 DAYS. ON (B)(6), WHEN NURSES WERE TURNING PATIENT OVER AND RE-POSITIONING PATIENT , AIR STARTED ENTERING THE ECMO CIRCUIT. THE CLINICIANS COULD NOT FIND WHERE AIR WAS COMING FROM. THE CLINICIANS ATTEMPTED TO DE-AIR THE CIRCUIT, BUT AIR STILL ENTERED. PATIENT WAS TAKEN OFF ECMO SUPPORT AND THEN 40 MINUTES LATER THE PATIENT DIED, AFTERWARDS, THE CLINICIANS INSPECTED THE CATHETER AND FOUND A CRACK RIGHT ALONG ONE OF THE BLACK LINES BELOW GOLD SUTURE AREA. THIS WAS THE SUSPECTED LOCATION WHERE THE AIR ENTERED THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022206 CRESCENT 28FR DUAL LUMEN CATHETER DUAL LUEM ECMO CANNULA PZS MC3 INC. 70128 10854916006932

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening