BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE DILATATION BALLOON

    MDR report key: 4781437 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00300
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OZT
    PMA / PMN Number
    K121083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE DEVICE WAS RETURNED. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR A LONGITUDINAL RUPTURE ON THE BARREL OF THE BALLOON. PER THE IFU, DURING CATHETER PREPARATION, AIR IS SUPPOSED TO BE REMOVED FROM THE CATHETER USING STANDARD CATHETER DE-AIRING TECHNIQUES. THE IFU DOES NOT STATE TO INFLATE THE BALLOON DURING PREPARATION, AS THE BALLOON IS ONLY MEANT TO BE INFLATED DURING USE WITHIN THE PATIENT. ADDITIONALLY, THE COMPLAINT COMMENTS MENTION THAT THE USER WAS MEASURING THE BALLOON WITH CALIPERS DURING INFLATION, WHICH COULD HAVE CONTRIBUTED TO THE RUPTURE. THE CONDITION OF THE RETURNED BALLOON DEMONSTRATED A HIGH PRESSURE RUPTURE, INDICATING THAT THE BALLOON WAS OVER PRESSURIZED PAST ITS RBP OF 6ATM. THE TRUE DILATATION BALLOON INSTRUCTION FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. DO NOT EXCEED MAXIMUM INFLATION PRESSURE INDICATED ON LABEL. EXCESS INFLATION PRESSURE CAN CAUSE BALLOON RUPTURE AND THE INABILITY TO WITHDRAW CATHETER THROUGH INTRODUCER SHEATH. 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 VALVULOPLASTY BALLOON RUPTURED DURING PREPARATION. THE DEVICE WAS NOT USED ON A PATIENT. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252796 TRUE DILATATION BALLOON OZT BARD PERIPHERAL VASCULAR, INC. PLN01412

    Patients

    Seq Age Sex Outcome Treatment
    1