BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACCESS PTA BALLOON DILATATION CATHETER

    MDR report key: 3940981 · Received April 23, 2014

    Report

    Report Number
    2020394-2014-00187
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER FOR THESE FAILURE MODES TO DATE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR RETRACTION ISSUES, AS THE BALLOON CATHETER WAS RECEIVED LODGED INSIDE THE 7F INTRODUCER SHEATH AND COULD NOT BE REMOVED DUE TO THE BULBOUS SHAPE AT THE DISTAL END OF THE BALLOON. THE DISTAL END OF THE SHEATH WAS CUT IN ORDER TO REMOVE THE BALLOON FROM THE SHEATH. THE BALLOON WAS ABLE TO BE SUCCESSFULLY ADVANCED AND RETRACTED THROUGH AN IN-HOUSE 7F INTRODUCER SHEATH WITH SLIGHT RESISTANCE DURING RETRACTION. THE INVESTIGATION IS UNCONFIRMED FOR DEFLATION ISSUES, AS THE DEVICE DEFLATED PROPERLY DURING FUNCTIONAL TESTING. PER THE EVENT DETAILS, THE BALLOON WAS UNABLE TO BE FULLY DEFLATED. THE RETRACTION ISSUE WERE A RESULT OF THE BALLOON NOT BEING FULLY DEFLATING PRIOR TO BEING RETRACTED INTO THE INTRODUCER SHEATH; HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE DEFLATION ISSUES COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE WITH THE FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE HEALTH PROFESSIONAL AT THE FACILITY DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WAS DIFFICULT TO DELATE AFTER USE IN THE UPPER ARM. THE BALLOON DILATION CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245152 VACCESS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93LX0201

    Patients

    Seq Age Sex Outcome Treatment
    1