BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATION CAATHETER

    MDR report key: 3810106 · Received April 10, 2014

    Report

    Report Number
    2020394-2014-00165
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS WERE REVIEWED AND THERE WAS NO EVIDENCE THAT THE FAILURE MODE REPORTED IN THIS COMPLAINT WAS MFG RELATED. THE LOT MET ALL RELEASE CRITERIA. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. IT IS UNK IF PT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.

    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 USER FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. RELEVANT TEST DATA, RELEVANT HISTORY, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE USER 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 SLOW TO DEFLATE AFTER THE INITIAL INFLATION OF 12 ATM DURING USE IN A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PROCEDURE. THE BALLOON WAS EVENTUALLY ABLE TO BE DEFLATED WITH ADDITIONAL MANIPULATION OF THE CATHETER AND WAS RETRACTED THROUGH THE INTRODUCER SHEATH WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216291 CONQUEST PTA BALLOON DILATION CAATHETER DQY BARD PERIPHERAL VASCULAR, INC. REXK0833

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR