BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1944004 · Received January 3, 2011

    Report

    Report Number
    9610978-2011-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON OF THE PALMAZ GENESIS STENT DELIVERY SYSTEM WOULD NOT INFLATE WHEN POSITIONED IN THE ILIAC ARTERY AS IT APPEARED TO HAVE A LEAK. THE PHYSICIAN HAD TO REMOVE THE SYSTEM AND TRY WITH ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED. NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE BALLOON OF THE PALMAZ GENESIS 7X18MM 135CM SDS WOULD NOT INFLATE. THE PHYSICIAN HAD TO REMOVE THE SYSTEM AND TRY WITH ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1