BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC AORTIC PUNCH 5.0MM

    MDR report key: 498586 · Received November 14, 2003

    Report

    Report Number
    MW1030255
    Event Type
    Injury
    Date Received
    November 14, 2003
    Report Date
    November 14, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    LRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUNCH NOT MAKING SMOOTH CUT. NOT AS SHARP AS IT NEEDS TO BE. DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/10/2004: THE UF VOLUNTARY REPORT DID NOT LIST OUTCOMES ATTRIBUTED TO THE EVENT. THE REPORT ALSO DID NOT LIST AN EVENT DATE AND MISTAKENLY NOTES THE PRODUCT WAS AVAILABLE FOR EVAL. THE ACTUAL DEVICE FROM THE EVENT WAS REPORTED TO MFR, INDICATED THE DEVICE WAS DISCARDED AT THE TIME OF SURGERY AND WOULD NOT BE RETURNED TO MEDTRONIC FOR INSPECTION. WITHOUT PRODUCT RETURN, AN EXACT CAUSE CANNOT BE DETERMINED FOR THE PRODUCT PROBLEM REPORTED. UNOPENED DEVICES FROM THE SAME MANUFACTURING LOT NUMBER WERE HOWEVER, AVAILABLE FOR EVAL. TESTING DONE BY MEDTRONIC REVEALED SMALL IMPERFECTIONS ON THE CIRCUMFERENCE OF THE PUNCH AND DIE OF THREE RETURNED DEVICES. ALTHOUGH THE UNITS WERE NOT TESTED ON SAMPLES OF TISSUE, THE SURFACE IRREGULARITY FOUND COULD HAVE CAUSED THE DULL CUT REPORTED BY THE USER. THE HCP DID NOT REPORT ANY PT INJURY OR MEDICAL INTERVENTION TO MEDTRONIC IN NOV. 2003. THE EXACT EVENT DATE WAS ALSO NOT PROVIDED. MFR'S INVESTIGATIONS OF THE INCIDENT SHOWS THAT ALTHOUGH THE PUNCHES MAY NOT HAVE BEEN AS SHARP, THE EVENT DID NOT, NOR WOULD NOT IN A RECURRENCE CAUSE OR CREATE THE POTENTIAL FOR SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC AORTIC PUNCH 5.0MM AORTIC PUNCH 5.0MM LRY MEDTRONIC CARDIAC SURGERY AP-550 0307000463

    Patients

    Seq Age Sex Outcome Treatment
    1 *