BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 3823437 · Received February 28, 2014

    Report

    Report Number
    2020394-2014-00064
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 11, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / 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 FACILITY WAS ABLE TO PROVIDE NEW PATIENT INFORMATION AND PRODUCT LOT#, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS. A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED; HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW, WHICH SHOWS A PTA BALLOON WITHIN A SHORT INTRODUCER SHEATH. THE DISTAL TIP AND A PORTION OF THE BALLOON IS PROTRUDING OUT OF THE DISTAL TIP OF THE SHEATH. THE DISTAL TIP OF T HE SHEATH DOES NOT APPEAR TO BE FLARED AND THERE ARE NO ANOMALIES VISIBLE TO THE BALLOON OR CATHETER. BASED UPON THE PHOTO REVIEW, RETRACTION ISSUES CANNOT BE CONFIRMED. THE INVESTIGATION IS INCONCLUSIVE AS THE SAMPLE WAS NOT RETURNED. THEREFORE, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON BECAME LODGED IN THE INTRODUCER SHEATH DURING RETRACTION. THE CATHETER AND SHEATH WERE REMOVED AS A SINGLE UNIT WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124960 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93LX0043

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR