BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP MALLEABLE SINGLE STAGE VENOUS CANNULA

    MDR report key: 19178947 · Received April 25, 2024

    Report

    Report Number
    2184009-2024-00221
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    November 13, 2023
    Report Date
    April 25, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K022272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A DLP MALLEABLE SINGLE STAGE VENOUS CANNULA, IT WAS REPORTED THAT DURING THE REPLACEMENT OF THE ARCH AND AN OPEN STENT, THE STERNAL CLOSURE WIRE OF THE INFECTED PATIENT WAS EXTRACTED AND THE WOUND WAS RE-SUTURED, BUT THE INFECTION CONTINUED. THE INFECTION OCCURRED AROUND THE SURGICAL STEEL WIRE, AND IT WAS REMOVED AND SUTURED AGAIN, BUT THE INFECTION WOUND DID NOT HEAL, AND A CT SCAN SHOWED A SEROMA LIKE MASS UNDER THE SUTURE SITE. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE USE OF MEDTRONIC PRODUCT IS UNKNOWN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SURGICAL STEEL WIRE WAS A NON-MEDTRONIC PRODUCT. THE CANNULA USED DURING THE CASE WAS A DLP CANNULA. THE CUSTOMER STATED THAT THE RELATIONSHIP BETWEEN THE INFECTION AND THE MEDTRONIC PRODUCT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659267 DLP MALLEABLE SINGLE STAGE VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF PERFUSION SYSTEMS 68128 2023041388

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention