BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONS PV .014

    MDR report key: 1922576 · Received November 19, 2010

    Report

    Report Number
    2939520-2010-00044
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. PRODUCT SPECIFICATION FOR THIS DEVICE INDICATES THAT THE MINIMUM GUIDE CATHETER SIZE TO USE IS 5F. HOWEVER, IT WAS REPORTED THAT A 4F SHEATH WAS USED WHICH MOST LIKELY CAUSED THE CATHETER TO GET STUCK ON THE SHEATH AND BECOME DAMAGE. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED FROM THE RIGHT BRACHIAL ARTERY. THE CATHETER WAS STUCK WITH SHEATH WHILE WITHDRAWING FROM THE LESION INSIDE THE ARTERY. (TARGET LESION: LEFT FEMORAL ARTERY, 90% STENOSED, NOT CALCIFIED). IT WAS REPORTED THAT WHEN THE PHYSICIAN PULLED THE CATHETER HARD TO REMOVE FROM THE SHEATH, THE CATHETER GOT DAMAGED, HOWEVER, THERE WAS NO REPORT OF MISSING MATERIAL. THE IVUS PROCEDURE WAS ACCOMPLISHED BY THIS CATHETER. THERE WAS NO INTERVENTION REPORTED DURING THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY OR EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV .014 INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 85910 063 01211

    Patients

    Seq Age Sex Outcome Treatment
    1