BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 3189765 · Received June 14, 2013

    Report

    Report Number
    3004114958-2013-00002
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 21, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY REPORT WAS NOT RECEIVED BY CARDICA FROM THE COMPLAINANT. THE REPORT WAS UNCOVERED IN A ROUTINE REVIEW OF MEDWATCH MAUDE DATABASE. ALLEGED MALFUNCTION CANNOT BE CONFIRMED. NO DEVICE WAS RETURNED TO CARDICA, SO INVESTIGATION WAS LIMITED TO A REVIEW OF THE MEDWATCH REPORT AND REVIEW OF LOT HISTORY RECORD (NO ANOMALIES FOUND) AND REVIEW OF SIMILAR COMPLAINTS FOR LOT #111227A. NO CONCLUSION CAN BE DRAWN. THE IDENTITY OF THE COMPLAINANT IS UNK, MAKING IT IMPOSSIBLE TO GATHER ADD'L INFO FOR ANY RESPONSE.

    Description of Event or Problem · 1

    HEALTHCARE REPORT (B)(4) ALLEGES THE "PAS-PORT DEVICE MISFIRED, REQUIRING FURTHER INTERVENTION AND THE PT TO BE PLACED ON BYPASS. DIAGNOSIS OR REASON FOR USE; CABG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272204 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCULAR SURGICAL INSTRUMENT FZP CARDICA, INC. NA 111227A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention