BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EOPA ARTERIAL CANNULA

    MDR report key: 19413278 · Received May 29, 2024

    Report

    Report Number
    2184009-2024-00327
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 19, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K031037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DEVICE WAS DRIZZLED WITH ROOM TEMPERATURE SALINE. DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. WITH SOME WATER APPLIED TO THE CAP/DILATOR INTERFACE THE SEAL BETWEEN THEM FELT LOOSE AT SEVERAL DIFFERENT PLACES. THE INTRODUCER OD, RED HEMOSTASIS CAP ID, CANNULA BODY LENGTH, AND THE DILATOR CUT LENGTH WERE MEASURED. INTRODUCER OD WAS MEASURED USING A CALIPER TO BE 0.268 INCHES, THE SPECIFICATION HAS THE OD TO BE 0.272 +0.002 / - 0.004 INCHES. HEMOSTASIS CAP ID WAS MEASURED USING A PLUG GAGE TO BE 0.262 INCHES, THE SPECIFICATION HAS THE ID TO BE 0.259 +/- 0.005 INCHES. THE CANNULA BODY LENGTH WAS MEASURED USING A RULER TO BE 10.5 INCHES, THE SPECIFICATION HAS THE LENGTH TO BE 10.544 TO 10.624 INCHES. THE INTRODUCER CUT LENGTH WAS MEASURED USING A RULER TO BE 13.4 INCHES, THE SPECIFICATION HAS THE LENGTH TO BE 13.310 TO 13.430 INCHES. A LEAK TEST WAS PERFORMED. HEMOSTASIS CAP TO PROVIDE WATER SEAL WITH LESS THAN 5 ML LEAK IN 30 SEC AT 80 MMHG (1.5 PSI) HEAD HEIGHT. THE HEMOSTASIS CAP/DILATOR INTERFACE DID LEAK PER THE TEST PROTOCOL. REASON FOR RETURN WAS CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A BLOOD LEAKAGE BETWEEN THE RED CAP AND THE WHITE STYLET. THE CUSTOMER STATED THAT THE DEVICE WAS LOOSE BETWEEN THE RED CAP AND THE WHITE STYLET. THE CUSTOMER ALSO STATED THAT THE DEVICE WAS TOO SMALL. THE PROBLEM WITH THIS ISSUE WAS THAT THE DEVICE TRAVELS TOO FAR INTO THE AORTA WHEN THE DEVICE IS INTRODUCED. THE CUSTOMER STATED THIS COULD CAUSE AN AORTIC INJURY AT THE BACK OR AN EMBOLIC SITUATION COULD OCCUR. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT DAMAGED, THE REPORTED COMPLAINT WAS NOT IN THE LOCATION OF THE SUTURES. PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK WAS APPROXIMATELY 50MLS. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939178 EOPA ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF PERFUSION SYSTEMS 77424 2023020187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown