BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3

    MDR report key: 923991 · Received March 27, 2007

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    Report

    Report Number
    9610978-2007-00185
    Event Type
    Malfunction
    Date Received
    March 27, 2007
    Date of Event
    March 22, 2007
    Report Date
    March 22, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    k981407
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO A SHUNT, THE BALLOON WAS REPORTED TO HAVE RUPTURED. THE VESSEL WAS DESCRIBED AS HAVING TERTIARY CALCIFICATION, UNK TORTUOUSITY AND A 99% STENOSIS. THERE WERE NO ABNORMALITIES NOTED DURING PRE-USE PROD INSPECTION. THE PROD WAS PREPPED AND USED PER THE IFU. THERE WAS NO REPORTED PT INJURY. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODS MET ALL REQUIREMENTS PER THE APPLICABLE MQP. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART # E7145022 WITH LOT# 0109050997 AND 0101060828. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PROD OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO A SHUNT, THE POWERFLEX P3 (4205020T) BALLOON RUPTURED AT 5ATM DURING INFLATION. THEREFORE, THE BALLOON WAS WITHDRAWN FROM THE PT'S BODY. THE VESSEL CONTAINED TERTIARY CALCIFICATION, UNK TORTUOUSITY AND A 99% STENOSIS. AN INDEFLATOR WAS USED DURING INFLATION. THERE WERE NO ABNORMALITIES NOTED DURING PRE-USE PROD INSPECTION. THE PROD WAS PREPPED AND USED PER THE IFU. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0106444

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GUIDEWIRE (RADIFOCUS/TERUMO)