BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIB CATHETER

    MDR report key: 7757950 · Received August 7, 2018

    Report

    Report Number
    1318694-2018-00010
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    November 23, 2017
    Report Date
    August 7, 2018
    Manufacturer
    NUMED, INC.
    Product Code
    NVM
    PMA / PMN Number
    K161451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NUMED, INC. WAS MADE AWARE OF INCIDENT FROM A RETURNED POST MARKET CLINICAL FOLLOW-UP FORM. INCIDENT WAS NOT REPORTED BY HOSPITAL. PHYSICIAN DID NOT THINK THE RUPTURE NECESSITATED A FORMAL COMPLAINT. CATHETER WAS NOT RETURNED. BALLOON BURST CAN NOT BE CONFIRMED. A COMPARATIVE CATHETER FROM A DIFFERENT LOT WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE LABELED RBP FOR THIS DEVICE IS 2.0 ATM. THE COMPARATIVE CATHETERS OUTER BALLOON WAS INFLATED IN 0.5 ATM INCREMENTS UNTIL RBP (2.0 ATM) WITH NO ISSUES. IT WAS THEN OVER INFLATED TO 5.0 ATM, WHICH IS MORE THAN DOUBLE THE RBP, WHERE IT BURST LONGITUDINALLY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. PROCEDURE WAS SUCCESSFUL. VERY LITTLE INFORMATION HAS BEEN RECEIVED, EVEN AFTER REPEATED ATTEMPTS.

    Description of Event or Problem · 1

    RUPTURE OF THE OUTER BALLOON AT 2 ATM AND FULL DIAMETER. WITHDRAWAL WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601269 BIB CATHETER STENT PLACEMENT CATHETER NVM NUMED, INC. 420.1 BIB-8895

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR