BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASPORT W/ATT/9.5 FR. CATH

    MDR report key: 2002773 · Received February 8, 2011

    Report

    Report Number
    1718850-2011-00006
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K882969
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VASPORT (VP150) IS A DEVICE THAT WAS MFG BY (B)(4). IN (B)(4) 2010, SORIN GROUP USA ACQUIRED (B)(4). IT WAS REPORTED THAT A VP150 CATHETER WAS FOUND BROKEN OFF IN A PT DURING REMOVAL OF THE DEVICE. THE CATHETER HAD BEEN IN THE PT, WHO HAD BREAST CANCER, FOR AT LEAST EIGHTEEN MONTHS OR LONGER. THE HOSPITAL HAS RETAINED THE PRODUCT. THE VP150 HAS NOT BEEN RETURNED FOR EVAL. PHOTOGRAPHS WERE SENT SHOWING A BREAK IN THE CATHETER LINE. SINCE THE PHYSICIAN DID NOT PERFORM X-RAY OR ULTRASONIC PHOTOGRAPHING BEFORE THE SURGERY, IT IS UNK IF THE VP150 WAS BROKEN OFF IN THE PT PRIOR TO SURGERY OR IF THE BREAK OCCURRED DURING REMOVAL. (B)(4) MFG OPERATIONS HAVE BEEN DISCONTINUED. MFG PERSONNEL ARE NO LONGER AVAILABLE. WITHOUT THE PHYSICAL DEVICE FOR EVAL, THE ROOT CAUSE OF THE BREAK CAN NOT BE DETERMINED. NO FURTHER ACTION IS NECESSARY. THERE WAS NO REPORT OF PT COMPLICATION DUE TO THE INCIDENT. THE FACILITY REPORTED THAT THE DEVICE BROKE OFF IN THE PT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VP150 CATHETER WAS FOUND BROKEN OFF IN A PT DURING THE REMOVAL OF THE DEVICE. THE PHYSICIAN DID NOT PERFORM X-RAY OR ULTRASONIC PHOTOGRAPHING BEFORE THE SURGERY. IT IS UNK IF THE VP150 WAS BROKEN OFF IN THE PT PRIOR TO SURGERY OR IF THE BREAK OCCURRED DURING REMOVAL. THERE WAS NO REPORT OF PT COMPLICATION DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASPORT W/ATT/9.5 FR. CATH CATHETER, PERCUTANEOUS DQY GISH BIOMEDICAL, INC. NA 003819

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR