BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTOPUS EVOLUTION TISSUE STABILIZER

    MDR report key: 1276846 · Received January 2, 2009

    Report

    Report Number
    2135394-2009-00001
    Event Type
    Injury
    Date Received
    January 2, 2009
    Date of Event
    December 4, 2008
    Report Date
    January 2, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    MWS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT, VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES TO THE DEVICE. HOWEVER, THE POD ARMS WERE SLIGHTLY BENT. FURTHER INSPECTION OF THE HEADLINK ASSEMBLY DID NOT IDENTIFY ANY SHARP EDGES, BURRS OR ROUGH AREAS ON THE COLLET OR PODS OF THE TISSUE STABILIZER. A REVIEW OF MANUFACTURING RECORDS DID NOT INDICATE ANY NON-CONFORMANCES PRIOR TO BEING RELEASED FOR DISTRIBUTION. CONCLUSION: BASED ON THE INFORMATION PROVIDED AND ANALYSIS RESULTS, USER INTERFACE CONTRIBUTED TO THIS EVENT. THE ABRASION WAS REPAIRED AND THE PATIENT FULLY RECOVERED FROM THE CABG/VALVE PROCEDURE. THERE ARE CURRENTLY NO TRENDS REGARDING THIS ISSUE. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT WHILE PERFORMING A DISTAL ANASTOMOSIS DURING AN ON-PUMP BYPASS PROCEDURE, AN ABRASION/TEAR OF THE MYOCARDIUM WAS OBSERVED AT THE TRANSITION OF THE FOOT TUBE ATTACHMENT (NOT THE BALL) TO THE PLASTIC SLEEVE OF THIS TISSUE STABILIZER. IT WAS NOTED THE CASE WAS A COMBINATION CABG/VALVE WITH THE BYPASS PROCEDURE PERFORMED FIRST OFF-PUMP. THE ABRASION WAS EASILY REPAIRED WHEN THE PATIENT WAS CONVERTED TO ON-PUMP FOR THE VALVE REPLACEMENT. THE TISSUE STABILIZER WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOPUS EVOLUTION TISSUE STABILIZER MWS MEDTRONIC PERFUSION SYSTEMS TS2000 2008101024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention