BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 4780892 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00207
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    November 13, 2014
    Report Date
    November 17, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. BASED UPON THE CONDITION IN WHICH THE SAMPLE WAS RETURNED, THE INVESTIGATION IS CONFIRMED FOR A PARTIAL BREAK AT THE BUTT JOINT AND A KINKED CATHETER. THE KINKED CATHETER AND THE BREAK AT THE BUTT JOINT LIKELY CONTRIBUTED TO THE REPORTED GUIDEWIRE ISSUES. THE INVESTIGATION IS INCONCLUSIVE FOR DEVICE-DEVICE INCOMPATIBILITY, AS THE REPORTED CONDITIONS OF USE COULD NOT BE RECREATED (I.E. PATIENT VESSEL). PER THE REPORTED EVENTS, THE GUIDEWIRE WAS REMOVED FROM THE BALLOON CATHETER TO INSERT CONTRAST THROUGH THE GUIDEWIRE PORT OF THE CATHETER.. HOWEVER, BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE IS UNK. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA CATHETER WOULD NOT RE-THREAD ONTO THE GUIDEWIRE. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252814 DORADO PTA BALLOON DILATATION CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. 93HY0115

    Patients

    Seq Age Sex Outcome Treatment
    1