BEUDAMED
    FDA Adverse Event Other Summary report: N

    PV 8.2 IVUS CATHETER

    MDR report key: 791288 · Received November 28, 2006

    Report

    Report Number
    2939520-2006-00002
    Event Type
    Other
    Date Received
    November 28, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 21, 2006
    Manufacturer
    VOLCANO THERAPEUTICS INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WAS IMAGING THE AORTA FOR AN AAA ENDOGRAFT CASE. AS THE CATHETER WAS REMOVED, THE DOCTOR FELT RESISTANCE NAD THE CATHETER TIP CAUGHT IN THE LEFT COMMON ILIAC TO EXTERNAL FEMORAL AREA OF THE PT. WHEN THE CATHETER WAS REMOVED, THE DOCTOR NOTICED THAT THE CATHETER TIP DID NOT COME OUT WITH THE REST OF THE CATHETER. THE CASE WAS ABORTED AND THE DECISION WAS MADE NOT TO RETRIEVE THE CATHETER TIP. A STENT WAS USED TO TRAP THE CATHETER TIP AGAINST THE ARTERIAL WALL. NO ADVERSE OUTCOME WAS REPORTED FOR THE PT AND THE PT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE RETURNED DEVICE WAS ANALYZED AT VOLCANO CORPORATION BY MANUFACTURING, R&D AND QUALITY. THE CATHETER APPEARED TO BE BUILT PER SPECIFICATIONS. THE OUTSIDE SURFACE OF THE EXPANDED SINGLE LUMEN HAD ABRASIONS CONSISTENT WITH BEING MOVED AGAINST SOMETHING HARD. THE TIP, SCANNER AND INNER MEMBER (30CM LENGTH) WERE MISSING. THE INNER MEMBER FAILED DUE TO THE FORCE USED TO FREE THE CATHETER. THIS WAS A MATERIAL BREAK AND NOT AN ADHESIVE BOND BREAK. THE CATHETER WAS MANUFACTURED TO SPECIFICATIONS. THE CATHETER WAS REMOVED WITH SIGNIFICANT FORCE TO CAUSE THE MATERIAL BREAK. PRODUCT LABELING CONTAINS PRECAUTIONS NOT TO ADVANCE GUIDE WIRE AGAINST SIGNIFICANT RESISTANCE, AND IF BINDING OCCURS BETWEEN CATHETERS AND GUIDE WIRE WHILE INSIDE THE PT TO CAREFULLY REMOVE BOTH THE WIRE AND CATHETER AND DO NOT USE.

    Description of Event or Problem · 1

    TIP OF CATHETER CAME OFF INSIDE PT DURING PROCEDURE. TIP OF CATHETER WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PV 8.2 IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER DQO VOLCANO THERAPEUTICS INC 88900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention