BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 4780913 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00199
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 9, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR A COMPLETE CIRCUMFERENTIAL OUTER CATHETER BREAK, AT THE PROXIMAL BUTT JOINT. THE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE SUPPLIER RELATED DUE TO OVER-PROCESSED RESIN. THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINT/ REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    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 INTERNATIONAL REPRESENTATIVE WAS ABLE TO PROVIDE THE DATE OF EVENT, DATE OF AWARENESS AND THE PATIENT¿S SEX, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BROKE AT THE PROXIMAL JOINT DURING AN BRACHIAL AVF ANASTOMOTIC STENOSIS. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252857 DORADO PTA BALLOON DILATATION CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. 93FY0208

    Patients

    Seq Age Sex Outcome Treatment
    1