BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-18 CONTROL WIRE

    MDR report key: 1970701 · Received January 25, 2011

    Report

    Report Number
    2134265-2011-00233
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE GUIDE WIRE WAS RETURNED WITH THE NON BSC CATHETER STUCK ON IT. VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE REVEALED ALL DEVICE MEASUREMENTS WERE WITHIN SPECIFICATIONS AND THE WIRE DID NOT PRESENT WITH ANY ANOMALIES. THE PTFE COATING ON THE GUIDE WIRE WAS IN PLACE AND IT CANNOT BE DETERMINED WHY THE GUIDE WIRE BECAME STUCK IN THE CATHETER. THE RETURNED UNIT PRESENTED WITH DRY BLOOD BETWEEN THE GUIDE WIRE AND THE CATHETER, WHICH WAS IMPEDING THE EASY REMOVAL OF THE GUIDE WIRE FROM THE CATHETER, HOWEVER, THIS DOES NOT EXPLAIN WHY THE GUIDE WIRE BECAME STUCK. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED UPON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DIFFICULTY LOADING A NON BSC BALLOON CATHETER ONTO THE GUIDE WIRE WAS ENCOUNTERED. THE ANATOMICAL LOCATION OF THE TARGET LESION IS UNKNOWN. A 300CM, 8CM V-18 GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, A NON BSC BALLOON CATHETER WAS "NOT ABLE TO PUSH OVER THE V-18 GUIDE WIRE". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED THE NON BSC BALLOON CATHETER WAS STUCK ON THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-18 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468540 0013431192

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER, PASSEO