BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED. ARTERIAL CANNULA

    MDR report key: 19069363 · Received April 9, 2024

    Report

    Report Number
    2184009-2024-00159
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    April 6, 2024
    Report Date
    May 2, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    UDI-DI
    00763000091101
    PMA / PMN Number
    K024069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF DAMAGE/SPLIT TOWARD THE TIP OF THE DEVICE. REASON FOR RETURN WAS CONFIRMED. CORRECTION B5. THE CUSTOMER STATED THAT IT WAS A SIGNIFICANT CRACK IN THE CANNULA BODY AND THEY DO NOT HAVE THE SPECIFIC DIMENSION OF THE CRACK. 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 A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK IN THE BODY OF THE DEVICE UPON SECURING THE CANNULA INTO THE AORTA WITH A 5-0 PROLENE AORTIC SUTURE. THE CRACK WAS LOCATED NEAR THE 1CM MARKER FROM THE DISTAL TIP. THE CUSTOMER STATED THAT IT WAS A SIGNIFICANT CRACK IN THE CANNULA BODY. THE DAMAGE WAS IN THE LOCATION OF THE SUTURES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512563 PED. ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF PERFUSION SYSTEMS 77008 2024020595 00763000091101

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Male