BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTOPUS NUVO TISSUE STABALIZER

    MDR report key: 1671925 · Received April 30, 2010

    Report

    Report Number
    2135394-2010-00008
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ANALYSIS: VISUAL INSPECTION SHOWED, THE THREE FINGERS WERE BROKEN OFF AND RETURNED LOOSE INSIDE THE BAG WHEN RECEIVED. THE FOURTH PIECE WAS RETAINED INSIDE THE SHAFT ASSEMBLY. PERFORMANCE TESTING WAS PERFORMED ON A RESERVE DEVICE, AS TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE RETURNED PRODUCT. THE DEVICE WAS SENT FOR EVALUATION OF THE MATERIAL INTEGRITY AND FOUND TO BE WITHIN SPECIFICATION. MULTIPLE ATTEMPTS WERE MADE TO RECREATE THE CLINICAL OBSERVATIONS. THE COLLET FRACTURE WAS RECREATED BY TIGHTENING THE WHALE TAIL TO A TORQUE OF 100 INCH POUNDS. THIS COULD ONLY BE ACHIEVED BY PLACING THE DEVICE IN A VICE AND TIGHTENING WITH A WRENCH. REVIEW OF MANUFACTURING RECORDS FOR THIS PRODUCT DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT DURING MINIMALLY INVASIVE CORONARY ARTERY BYPASS, THIS OCTOPUS NUVO DEVICE EXHIBITED A POPPING SOUND. THE COLLET THAT ATTACHES TO THE SHAFT OF THE HANDLE AND THAT HOLDS THE HEADLINK STABLE, HAD FRACTURED. AT THE SAME TIME, THE WHALE TAIL AND INTERNAL DEVICE SHAFT LOOSENED AND SLID OUT FROM THE HANDLE. THE HEADLINK COLLET, IT WAS DETERMINED, HAD FRACTURED INTO THREE SEPARATE PIECES; ONE THAT REMAINED WITHIN THE SHAFT, ONE THAT WAS RETRIEVED JUST OUTSIDE OF THE THORACOTOMY INCISION, AND ONE THAT WAS RETRIEVED WITHIN THE CHEST CAVITY ONCE LOCATED BY X-RAY. THERE WAS OTHERWISE NO PATIENT HARM. DESPITE THIS FRACTURE, THE HEADLINK ITSELF REMAINED IN POSITION, AND THE SURGEON COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOPUS NUVO TISSUE STABALIZER DWS MEDTRONIC PERFUSION SYSTEMS TSMICS1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention