BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST 40 PTA BALLOON DILATATION CATHETER

    MDR report key: 4780933 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00244
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    January 9, 2015
    Report Date
    January 16, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS 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 TO DATE FOR THIS FAILURE MODE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR PEELED MATERIAL AS THE OUTER LAYER OF PEBAX AND CIRCUMFERENTIAL FIBERS WERE PEELING OFF THE BALLOON. IT IS LIKELY THAT THE USER PERCEIVED THE PEELED PEBAX AND CIRCUMFERENTIAL FIBERS AS BEING UNRAVELED BALLOON FIBERS. THE BALLOON WAS INFLATED WITHIN A STENT A THERE MAY HAVE BEEN AN INTERACTION BETWEEN THE STENT AND BALLOON WHICH CONTRIBUTED TO THE PEELED PEBAX FIBERS. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE PEELED PEBAX AND FIBERS COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. THE CONQUEST INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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 USER FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE USER FACILITY WAS ABLE TO PROVIDE NEW PROCEDURAL INFORMATION, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOOON BECAME UNRAVELED IN AN IN-STENT RESTENOSIS. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252940 CONQUEST 40 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REYA1233

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR