BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1015776 · Received March 18, 2008

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    Report

    Report Number
    9610978-2008-00074
    Event Type
    Malfunction
    Date Received
    March 18, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7136989 WITH LOT NUMBER 0306060606. THIS REVIEW REVEALED THAT HE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. THIS PRODUCT IS AVAILABLE; HOWEVER, IT HAS NOT BEEN RECEIVED FOR ANALYSIS. ADD'L INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO THE ILIACA COMMUNIS, THE BALLOON OF THE PALMAZ GENESIS OPTA PRO RUPTURED AT UNK ATMS. THE EVENT MOST LIKELY OCCURRED BEFORE INFLATION; HOWEVER, WHEN INFLATING THE BALLOON, A LEAK WAS NOTICED AND THE BALLOON WOULD NOT INFLATE. THE STENT DELIVERY SYSTEM WAS RETRIEVED WITHOUT DIFFICULTY. THE LESION WAS VERY CALCIFIED. THE LESION WAS APPROACHED CONTRALATERALLY. THE PT HAD CLAUDICATION. THE STENT WAS NEVER IMPLANTED AND NEVER DEPLOYED FROM THE SYSTEM. AFTER PULLING BACK THE GUIDING CATHETER FROM PROTECTING THE STENT, THE PHYSICIAN MOVED THE WHOLE STENT SYSTEM A LITTLE BIT, WHICH MAY HAVE CAUSED THE BALLOON RUPTURED. ANOTHER GENESIS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    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 R0606159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BARD'S MECHANICAL INFLATION DEVICE| 45CM SHEATH| TERUMO WIRE