BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANCUT ROTATING AORTIC PUNCH

    MDR report key: 2542722 · Received April 10, 2012

    Report

    Report Number
    1649914-2012-00005
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 12, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AN AORTIC PUNCH MALFUNCTIONED. THE PHYSICIAN REPORTED THAT THE PUNCH RIPPED A HOLE IN THE AORTA. HE REPAIRED THE TEAR WITH SUTURES AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE HOSPITAL DID NOT KEEP THE PACKAGING TO PROVIDE DEVICE IDENTIFICATION INFO. THE PUNCH HAS NOT BEEN RETURNED TO THE MFR FOR ANALYSIS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEANCUT ROTATING AORTIC PUNCH AORTIC PUNCH DWS QUEST MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention