BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION CATHETER

    MDR report key: 2545688 · Received January 22, 2009

    Report

    Report Number
    2939520-2009-00036
    Event Type
    Other
    Date Received
    January 22, 2009
    Date of Event
    November 28, 2008
    Report Date
    January 23, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO IMPACT TO PT OR USER. THE CATHETER WAS ANALYZED AND INSPECTED UPON RECEIPT, NO DAMAGE WAS FOUND. MFG INFO AND PREVIOUS COMPLAINT DATA WAS REVIEWED AGAINST THE LOT NUMBER, AND NO IRREGULARITIES WERE FOUND. NO EVIDENCE WAS SEEN THAT WOULD CONCLUDE THAT THE DEVICE WAS MFG OUT OF SPECIFICATION. IN THE PAST, A SEVERELY KINKED GUIDE WIRE (AS WAS FOUND IN THIS CASE) HAS BEEN FOUND TO BE ATTRIBUTED TO THIS FAILURE MODE. ALTHOUGH THERE WAS NO PT IMPACT ASSOCIATED WITH THIS OCCURRENCE, IF THE EVENT WERE TO REOCCUR, THERE COULD BE A POTENTIAL FOR INJURY. THIS REPORT IS BEING SENT AS A NOTIFICATION. COMPLAINT CONFIRMED AS MDR REPORTABLE (B)(4) 2008 UPON INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A GUIDING WIRE 'NEO'S ROUTE' BY ASAHI INTECC CO. GOT STUCK WITH THE REVOLUTION SHAFT AT THE WIRE PORT DURING THE PROCEDURE. THE LESION WAS AT #15 AND 90% OCCLUDED BUT NOT CALCIFIED NOR TORTUOUS ARTERY, ACCESS WAS FROM A FEMORAL ARTERY. THIS CATHETER WAS ALTERNATIVELY USED FOR THE PROCEDURE INSTEAD OF THE PREVIOUS ONE ((B)(4)) WHICH FAILED WITH THE SAME PROBLEM OF STUCK AT THE WIRE EXPORT BUT THIS CATHETER WAS NOT ABLE TO BE PULLED OUT ONLY BY THIS PRODUCT, THEREFORE IT WAS PULLED OUT WITH THE GUIDE WIRE ALL TOGETHER. THE DEVICES USED WITH FOR THE PROCEDURE WAS A S5R SYSTEM, A GUIDING CATHETER OF 6FR 'MACH 1' BY BOSTON SCIENTIFIC CORP., A STENT DEVICE LIBERTY AND A SHEATH BY TERUMO. THE GUIDE WIRE AND BOTH CATHETERS WERE COLLECTED BY (B)(6) AND HAVE BEEN RETURNED TO VOLCANO. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CATHETER INTRAVASCULA ULTRASOUND CATHETER (IVUS) OBJ VOLCANO CORPORATION 89000 035 02029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other