BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SADDLELOOP

    MDR report key: 6071535 · Received November 1, 2016

    Report

    Report Number
    1649914-2016-00053
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 4, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    GAE
    PMA / PMN Number
    PRE-AMENDMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION 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.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE COMPLAINT SAMPLE FOUND THAT THE TENSIONER HAD COME OFF OF THE TAPE/SILICONE TUBE. NO ADHESIVE WAS SEEN UNDER BLACK LIGHT. THE ADHESIVE DISPENSER WAS NOT FUNCTIONING PROPERLY RESULTING IN INADEQUATE AMOUNT OF ADHESIVE DISPENSED. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR (B)(6) REPORTED AN ISSUE ENCOUNTERED WITH THE SADDLELOOP DEVICE BY ONE OF THEIR CUSTOMERS DURING A PROCEDURE. THE REPORT STATED THAT THE PROCEDURE WAS A CORONARY ARTERY BYPASS GRAFTING (CABC), WITH AORTIC VALVE REPLACEMENT (AVR) AND MAZE. THE REPORT STATED THAT WHILE A TERMINAL ANASTOMOSIS OF CABG WAS BEING PERFORMED, THE CLINICIAN PUT THE SADDLELOOP AROUND THE VESSEL AND ATTEMPTED TO PUSH THE NEEDLE THROUGH THE LOCKING MECHANISM BUT THE LOCKING MECHANISM DETACHED FROM THE TUBING. AS A RESULT, THE CLINICIAN USED A SADDLELOOP DEVICE FROM ANOTHER PACKAGE TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722682 SADDLELOOP MANUAL SURGICAL INSTRUMENT GAE QUEST MEDICAL, INC. 1541 0501965N05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention