BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIB STENT PLACEMENT CATHETER

    MDR report key: 23200775 · Received October 2, 2025

    Report

    Report Number
    1318694-2025-00006
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 2, 2025
    Manufacturer
    NUMED, INC.
    Product Code
    NVM
    PMA / PMN Number
    K160889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED FOR REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS DEVICE LOT NUMBER. A REVIEW WAS ALSO PERFORMED ON THE BALLOON TUBING USED TO MANUFACTURE THESE BALLOONS. NO OTHER COMPLAINTS WERE ASSOCIATED WITH THE RUBING USED TO MANUFACTURE THE BALLOONS. REVIEW OF DATA FROM THE PHYSICIAN / USER FACILITY SHOWS THAT THE DEVICE WAS NOT USED ACCORDING TO THE INSTRUCTIONS FOR USE. THE BIB CATHETER IS A BALLOON IN BALLOON CATHETER THAT WAS DESIGNED TO HAVE THE INNER BALLOON INFLATED PRIOR TO THE INFLATION OF THE OUTER BALLOON. IT WAS TESTED THIS WAY WITH BOTH THE CP STENTS AND THE G-ARMOR STENTS THAT ARE MANUFACTURED BY NUMED. THIS BIB CATHETER WAS BEING USED TO INFLATE AN ANDRATEC STENT THAT WAS IMPLANTED PREVIOUSLY IN THE AORTA (AN OFF LABEL USED OF THIS CLASS II STENT). IT WAS NOTED IN THE REPORT THAT THE BALLOON BURST AND IT COULD NOT BE REMOVED FROM THE PATIENT BECAUSE IT WAS CATCHING ON THE PREVIOUSLY IMPLANTED ANDRATEC STENT. IT IS BELIEVED THAT THE SHARP EDGES OF THE ANDRATEC STENT CAUSED THE OUTER BALLOON OF THE BIB CATHETER TO BURST. A COMPARATIVE CATHETER WAS PULLED AND TESTED. THE DEVICE WAS THE SAME CATALOG NUMBER BUT WAS FROM A DIFFERENT MANUFACTURING LOT. THE BALLOONS WERE IMMERSED IN A BODY TEMPERATURE WATER BATH. THE INNER BALLOON WAS INFLATED TO ITS LABELED RATED BURST PRESSURE OF 5 ATM, AND THEN THE OUTER BALLOON WAS INFLATED TO ITS LABELED RATED BURST PRESSURE OF 4 ATM. THERE WERE NO ISSUES. THE OUTER BALLOON WAS THEN INFLATED UNTIL IT BURST, WHICH DID NOT OCCUR UNTIL 9 ATM. THE OUTER BALLOON BURST IN A LONGITUDINAL DIRECTION. THE INNER BALLOON WAS THEN INFLATED UNTIL IT BURST, WHICH DID NOT OCCUR UNTIL 12 ATM. THE INNER BALLOON BURST IN A LONGITUDINAL DIRECTION. BOTH BALLOONS DID NOT BURST UNTIL THEY WERE INFLATED TO MORE THAN DOUBLE THEIR LABELED RATED BURST PRESSURE. THE ROOT CAUSE OF THE COMPLAINT IS BEING ATTRIBUTED TO THE DEVICE NOT BEING USED AS PER THE INSTRUCTIONS FOR USE. ACCORDING TO THE PHYSICIAN, THE INNER BALLOON WAS NOT INFLATED AT ALL. THE PHYSICIAN STATED IN HIS RESPONSE TO THE FOLLOW UP QUESTIONS THAT THE ANDRATEC STENT WAS NOT COVERED ON BOTH SIDES, SO MOST LIKELY THE SHARP EDGES PLAYED A ROLE IN THE BALLOON BURST.

    Description of Event or Problem · 0

    BIB BALLOON BURST WHEN REDILATING A PREVIOUSLY PLACED ANDRATEC STENT IN THE AORTIC POSITION (OFF LABEL USED OF THIS STENT). THE BALLOON COULD NOT BE RECOVERED AFTER SNARING DESPITE STRONG USED OF FORCE. IT WAS CATCHING ON THE PREVIOUSLY IMPLANTED ANDRATEC STENT. THE BALLOON COULD ONLY BE RECOVERED SURGICALLY. NO LONG-TERM COMPLICATIONS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318898 BIB STENT PLACEMENT CATHETER STENT PLACEMENT CATHETER NVM NUMED, INC. 420.1 BIB-17519

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other