BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER

    MDR report key: 1719769 · Received June 4, 2010

    Report

    Report Number
    1820334-2010-00253
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 7, 2010
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    PMA / PMN Number
    K073378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THIS INVESTIGATION. PER DFMEA (DESIGN FAILURE MODES AND EFFECT ANALYSIS): BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING PERFORMED. THE RATED BURST PRESSURE (14 ATM) IS DOCUMENTED IN THE IFU AND LABEL. THE DEVICE IS INSPECTED PER QC TO ENSURE BONDS AND BALLOON ARE UNDAMAGED. EACH DEVICE IS LEAK TESTED. EACH DEVICE IS SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THE COMPLAINT CORRESPONDENCE INDICATES THAT THE PHYSICIAN WAS TREATING A HEAVILY CALCIFIED LESION. THE CALCIFICATION LIKELY CONTRIBUTED TO THE RUPTURE AS AN ADD'L TWO NON-COOK DEVICES WERE USED AND RUPTURED AS WELL. THERE WAS NO INDICATION THAT A PRESSURE GAUGE WAS USED TO INFLATE. THE INFLATION PRESSURES WERE NOT REPORTED. THE PHYSICIAN DECIDED TO REMOVE THE WIRE GUIDE TO INJECT CONTRAST AND HAD DIFFICULTY REINSERTING. IT IS REASONABLE TO SUGGEST THAT ONCE THE PHYSICIAN LOST THE ACCESS, IT WAS DIFFICULT TO CROSS AGAIN AS THE LESION WAS HEAVILY CALCIFIED AND THE BALLOON HAD RUPTURED. THIS RESULTED IN THE WIRE PUNCTURING THE CATHETER SHAFT. THE DEVICE WAS REMOVED AND COMPLAINT CORRESPONDENCE INDICATED A CIRCUMFERENTIAL RUPTURE, WHICH COULD BE EXPECTED IF THE BALLOON IS HIGHLY CONSTRICTED. THE COMPLAINT WILL BE UPDATED IF THE DEVICE IS RETURNED. COMPLAINT WILL BE TRENDED AS NEGLIGIBLE HARM AS NO HARM TO THE PT WAS REPORTED. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE DR WANTED TO POST DILATE A SELF EXPANDING STENT THAT HE PLACED IN THE ARTERY WITH A LOW PROFILE BALLOON. HE PLACED THE BALLOON OVER A .018" ROADRUNNER WIRE AND SUCCESSFULLY CROSSED THE LESION. HE HAND INFLATED THE BALLOON, HOWEVER, THE BALLOON HAD RUPTURED; POSSIBLY DUE TO THE FACT THAT THE ARTERY WAS HEAVILY CALCIFIED. HE TOOK THE WIRE OUT TO INJECT SOME CONTRAST AND THEN WENT TO PUT THE WIRE BACK IN, BUT COULDN'T GET THE WIRE ACROSS THE LESION. HE THEREFORE TOOK THE WIRE AND BALLOON OUT TOGETHER AND NOTICED THAT THE ACTUAL BALLOON HAD COME AWAY FROM THE CATHETER AND THAT THE WIRE WAS GOING THROUGH THE SIDE OF THE CATHETER AND NOT THE ENDHOLE AS IT IS SUPPOSED TO. PLEASE NOTE THAT THE DR PREVIOUSLY HAD TRIED TO POST INFLATE THE STENT WITH TWO OTHER BALLOONS AND THESE ALSO RUPTURED. ADD'L INFO RECEIVED 10/05/2010: THE TWO ADD'L BALLOONS THAT ALSO RUPTURED WERE NON COOK DEVICES. THE PROCEDURE WAS EVENTUALLY COMPLETED USING A NON COOK DEVICE. NO HARM TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER KCG DILATOR, TRACHEAL KCG COOK, INC. NA 2377646

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK