BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANCUT ROTATING AORTIC PUNCH, 4MM

    MDR report key: 2662854 · Received July 17, 2012

    Report

    Report Number
    1649914-2012-00016
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    June 18, 2012
    Report Date
    June 20, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE FOREIGN ((B)(4)) DISTRIBUTOR RECEIVED A REPORT FROM THE HOSPITAL THAT ON (B)(6) 2012, A ROTATING PUNCH MALFUNCTIONED DURING A VEIN GRAFT PROCEDURE. IT WAS REPORTED THAT THE PUNCH WAS PLACED INTO THE AORTA TO PUNCH A HOLE, BUT THE DEVICE BECAME STUCK. THE PUNCH WOULD NOT RELEASE AND HAD TO BE CUT OUT. IT WAS REPORTED THAT ANOTHER PUNCH WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE ALLEGED INCIDENT. THE MANUFACTURER HAS NOT YET RECEIVED THE PUNCH THAT MALFUNCTIONED FOR ANALYSIS. THE DISTRIBUTOR HAS INDICATED IT HAS RECENTLY BEEN SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEANCUT ROTATING AORTIC PUNCH, 4MM INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS QUEST MEDICAL, INC. RCL40 0411581D10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention