BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTCUT ROTATING AORTIC PUNCH

    MDR report key: 4080505 · Received July 24, 2014

    Report

    Report Number
    1649914-2014-00034
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 3 OF 3. QUEST MED INC HAS LIMITED INFO RELATED TO THE PATIENT'S MED 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

    DEVICE 3 OF 3. REFER TO 1649914-2014-00033 AND 1649914-2014-00032. THE FOREIGN HOSP (B)(6)REPORTED DEVICE MALFUNCTIONS INVOLVING THE AORTIC PUNCH DURING THREE PROCEDURES. THE CLINICIAN REPORTED THAT IN EACH INSTANCE THE PUNCH FAILED TO MAKE THE CUT AS DESIRED, BUT INSTEAD WHEN ACTIVATED THE RELEASE MECHANISM BECAME STUCK IN THE AORTIC WALL. ANOTHER PUNCH (DIFFERENT MFR) WAS USED TO SUCCESSFULLY COMPLETE EACH OF THE PROCEDURES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED MALFUNCTIONS. IT IS ANTICIPATED THAT THE DEVICES (3 IN TOTAL) WILL BE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432945 PERFECTCUT ROTATING AORTIC PUNCH DWS QUEST MEDICAL, INC. RCB40 0447163U02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention