BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP PERICARDIAL/INTRACARDIAC SUMPS

    MDR report key: 1051856 · Received May 22, 2008

    Report

    Report Number
    2184009-2008-00032
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K850385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT, VISUAL INSPECTION OF THIS CANNULA CONFIRMED THAT THE SUMP TIP WAS COMPLETELY DETACHED FROM THE CANNULA BODY. THE TIP OF THE CANNULA COULD NOT BE INSPECTED, AS IT WAS NOT RETURNED FOR ANALYSIS. FURTHER INSPECTION REVEALED SOLVENT BOND RESIDUE 360 DEGREES SURROUNDING THE CANNULA BODY TIP, WHICH INDICATES ADHESIVE WAS APPLIED DURING THE MANUFACTURING PROCESS. IN ADDITION, A SLIGHT APPEARANCE CHANGE (MORE CLEAR) WAS OBSERVED AT THE BONDED TIP END OF CANNULA. ANALYSIS WAS UNABLE TO DETERMINE WHAT CAUSED THE SUMP TIP TO SEPARATE FROM THE CANNULA BODY DURING USE. THE CANNULA WAS FORWARDED TO THE SUPPLIER FOR DETAILED ANALYSIS IN AN EFFORT TO DETERMINE ROOT CAUSE FOR THIS INCIDENT. CONCLUSION: VISUAL INSPECTION CONFIRMED THE SUMP TIP HAD DETACHED FROM THE CANNULA BODY AND SOLVENT BOND RESIDUE WAS USED DURING THE MANUFACTURING PROCESS. THE DEVICE WAS FORWARDED TO THE SUPPLIER FOR DETAILED ANALYSIS AND TO DETERMINE ROOT CAUSE FOR THIS INCIDENT. WHEN ADD'L INFO IS RECEIVED, THIS EVENT WILL BE UPDATED AND A FOLLOW-UP WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING THE ROBOTIC MAZE PROCEDURE, THE TIP OF THIS CARDIAC SUMP CANNULA DETACHED FROM THE CANNULA BODY WHILE EXTRACTING FROM THE PT'S CHEST. IT WAS NOTED THAT DURING THE PROCEDURE, THE DEVICE ESSENTIALLY WAS LAYING IN THE CHEST, BEING USED AS A SUMP. THE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PT, AND THERE WERE NO ADVERSE OUTCOMES REPORTED. ONLY THE CANNULA BODY WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP PERICARDIAL/INTRACARDIAC SUMPS DWF MEDTRONIC PERFUSION SYSTEMS 12112 2006100305

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R