BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS GOLD PTA BALLOON DILATATION CATHETER

    MDR report key: 4201069 · Received September 16, 2014

    Report

    Report Number
    2020394-2014-00425
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K122984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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 HEALTH PROFESSIONAL AT THE USER FACILITY DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME. 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

    THE DEVICE HISTORY RECORD WAS REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. THE DEVICE WAS RETURNED. THE INVESTIGATION WAS CONFIRMED FOR A BALLOON DETACHMENT AND FOR RETRACTION ISSUES BASED ON THE CONDITION OF THE RETURNED SAMPLE (I.E. PROLAPSED BALLOON MATERIAL OVER DISTAL TIP AND FLARED TIP OF INTRODUCER SHEATH). THE INVESTIGATION IS INCONCLUSIVE FOR A BALLOON RUPTURE, AS NO RUPTURES WERE OBSERVED AND FUNCTIONAL TESTING TO INFLATE THE BALLOON COULD NOT BE PERFORMED DUE TO THE POOR SAMPLE CONDITION. PER THE EVENT DETAILS, THE BALLOON WAS INFLATED IN 24ATM FOR THE FIRST INFLATION AND 28ATM FOR THE SECOND INFLATION. THE BALLOON RUPTURED ON THE THIRD INFLATION AT 12ATM. THE RATED BURST PRESSURE (RBP) FOR THIS BALLOON SIZE IS 18ATM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AT 12ATM DURING THE THIRD INFLATION IN AN A/V FISTULA IN THE ARM. DURING RETRACTION, THE BALLOON DETACHED WITHIN THE SHEATH. THE SHEATH AND BALLOON WERE REMOVED TOGETHER AS A SINGLE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572426 ATLAS GOLD PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR 93EY0181

    Patients

    Seq Age Sex Outcome Treatment
    1