BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURAFLOW SYSTEM WITH FLOWGLIDE

    MDR report key: 16966906 · Received May 19, 2023

    Report

    Report Number
    3008782989-2023-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 18, 2023
    Manufacturer
    CLEARFLOW, INC.
    Product Code
    OTK
    UDI-DI
    00856449006192
    PMA / PMN Number
    K203394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ROOT CAUSE OR DEVICE ASSOCIATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED FOR SURGERY ON APRIL 20TH AND HAD A CABG X 2/AVR. THE SURGEON PLACED TWO MEDIASTINAL CHEST TUBES (1) PFFG3-28 AND (1) 24FR CHEST TUBE FROM ANOTHER MANUFACTURER (NOT IDENTIFIED). THESE TWO CHEST TUBES WERE PLACED ANTERIORLY IN THE MEDIASTINUM. A THIRD CHEST TUBE, PFFG3-28 RA, WAS PLACED IN THE LEFT PLEURAL SPACE. UPON ATTEMPTING THE FIRST ACTUATION OF THE MEDIASTINAL CHEST TUBE (PFFG3-28), THE SHUTTLE GUIDE AND CLEARANCE WIRE DECOUPLED IMMEDIATELY. THE DECISION WAS TO CLOSE THE STERNUM AND LEAVE IT IN THIS POSITION AND INFORM THE CVICU TEAM TO NOT TRY AND WITHDRAW THE SHUTTLE AND CLEARANCE WIRE PER THE IFU. UPON LANDING IN THE CVICU, THE PATIENT WAS BLEEDING HEAVILY AND AFTER ONE (1) LITER OF DRAINAGE OUTPUT IN THE FIRST HOUR, THE DECISION WAS MADE TO RETURN THE PATIENT TO THE OR FOR RE-EXPLORATION. THE PATIENT'S CHEST WAS OPENED, AND THEY DISCOVERED A DEHISCENCE OF THE DISTAL ANASTOMOSIS OF THE LIMA-LAD GRAFT THAT WAS THE CAUSE FOR THE BLEEDING. THE SURGEON RE-ANASTOMOSED, ACHIEVED HEMOSTASIS, AND CLOSED THE CHEST. IT WAS REPORTED BY THE SURGEON THAT DURING THE RE-EXPLORATION THE MAGNETIC SHUTTLE GUIDE AND CLEARANCE WIRE WERE NOT WORKING (DECOUPLING), SO HE REMOVED IT. SINCE THE CHEST TUBE WAS NOT RETURNED TO THE COMPANY AND NO PHOTOS WERE PROVIDED, THE CAUSE OF DECOUPLING COULD NOT BE ESTABLISHED. THE RETURNED CLEARANCE WIRE ASSEMBLY WAS EVALUATED, AND IT WAS DETERMINED THAT IT MET APPLICABLE SPECIFICATIONS. A REVIEW OF MANUFACTURING RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS. IT IS NOT DEMONSTRATED THAT THE DEVICE PERFORMANCE IS ASSOCIATED WITH THE PERFORMED RE-EXPLORATION. THE CLEARANCE WIRE ASSEMBLY WAS RETURNED TO THE COMPANY FOR INVESTIGATION. SINCE ONLY THE CLEARANCE WIRE WAS RETURNED TO THE COMPANY FOR INVESTIGATION (THE CHEST TUBE AND REMAINDER OF THE DEVICE WERE NOT RETURNED), IT IS BELIEVED THAT THE CHEST TUBE REMAINED IN PLACE AFTER RE-EXPLORATION. PATIENT RECOVERED THEREAFTER AND IT WAS REPORTED BY NURSING STAFF THAT BASED ON THE POSITION OF THE CHEST TUBES RELATIVE TO THE AREA OF BLEEDING, THE DEVICE HAD NO CAUSE/EFFECT ON THE SURGICAL BLEEDING ISSUE. THE SURGEON PERFORMING RE-EXPLORATION DID NOT DETERMINE IF THE DEVICE CONTRIBUTED TO THE PATIENT RETURNING FOR BLEEDING. IT WAS REPORTED THAT THE PATIENT RECOVERED NORMALLY AFTER THE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623656 PLEURAFLOW SYSTEM WITH FLOWGLIDE CHEST TUBE OTK CLEARFLOW, INC. PFFG3-28 UNKN 00856449006192

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention