BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2223756 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05949
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: IN THIS CASE, A CONCLUSIVE CAUSE FOR THE OPENED POUCH COULD NOT BE DETERMINED; HOWEVER, THE PRESENCE OF THE SEAL WAS VISIBLE SUGGESTING THAT THE SEAL WAS ORIGINALLY INTACT AND THE MANUFACTURING SEAL WAS SEALED AND INTACT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATA-BASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL ABSOLUTE PRO STENT SYSTEMS AND PACKAGING ARE SUBJECTED TO A VISUAL INSPECTION DURING PACKAGING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BOX OF THE ABSOLUTE WAS OPENED, THE SIDE OF THE POUCH WAS OBSERVED TO BE UNSEALED. SINCE THE STERILITY WAS BREECHED, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1041161

    Patients

    Seq Age Sex Outcome Treatment
    1