BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1923335 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02692
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: WHISPER ES. STENT: ZETA 3X15. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED CATHETER NOTED BLOOD VISIBLE ON THE ENTIRE LENGTH OF THE SHAFT, INDICATING THAT THE CATHETER WAS ADVANCED INSIDE THE PATIENT. THERE WAS A CRYSTALLIZED YELLOW FLUID VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, WHICH INDICATES THAT THE DEVICE WAS PREPARED FOR USE AND SUGGESTS THAT THE BALLOON WAS PRESSURIZED AT SOME POINT. THIS APPEARS TO BE INCONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE COULD NOT BE POSITIONED/VISUALIZED DURING THE PROCEDURE. ALTHOUGH IT CANNOT BE CONFIRMED WHEN THIS OCCURRED, CLARIFICATION RECEIVED FROM THE ACCOUNT STATED THAT THE PHYSICIAN MAY HAVE TRIED TO INFLATE THE BALLOON, BUT DUE TO THE REPORTED ISSUE, IT WAS REPLACED. FURTHERMORE, THE YELLOW COLOR PIGMENT COULD BE BECAUSE OF CIDEX/GLUTEREX, WHICH IS USED ON DISCARDED DEVICES. THE ANALYSIS REVEALED THAT BOTH BALLOON MARKERS WERE DISINTEGRATED, CAUSING MULTIPLE LOOSE MARKER PARTICLES TO BE SPREAD THROUGHOUT THE BALLOON AND THE INFLATION LUMEN. IF THE MARKERS WERE DISINTEGRATED DURING AN ATTEMPT TO ADVANCE THE CATHETER, THIS COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT DURING PLACEMENT OF THE BALLOON WITHIN THE LESION. ADDITIONAL TESTING WAS PERFORMED TO PRESSURIZE THE CATHETER TO THE RATED BURST PRESSURE, AND THE BALLOON INFLATED WITHOUT ANY ANOMALIES NOTED. THIS TYPE OF DAMAGE IS NOT A TYPICAL FAILURE MODE FOR BALLOON MARKERS AND HAS NOT BEEN SEEN BEFORE AS A RESULT OF A MANUFACTURING DEFICIENCY. IT WAS HYPOTHESIZED THAT THIS TYPE OF DAMAGE MAY OCCUR FROM FACTORS SUCH AS, BUT NOT LIMITED TO, EXTREME TEMPERATURES/HUMIDITY CONDITIONS, RAPID RESTERILIZATION OF A PRODUCT, OR DAMAGE DURING MANUFACTURING. IN THIS CASE, ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT, A NON-IONIC CONTRAST IS USED UNDER FLUOROSCOPY AND 3M HAND RUB, WHICH IS AN ANTI INFECTIVE AGENT, IS USED DURING ETO AND IN THE CATH LAB. ETO MAY STAND FOR ETHYLENE OXIDE, A GAS MAINLY USED TO STERILIZE MEDICAL AND PHARMACEUTICAL PRODUCTS. ETO IS USED TO STERILIZE THE VOYAGER NC PRODUCT ONE TIME ONLY BEFORE IT IS DISTRIBUTED TO CUSTOMERS. SINCE ABBOTT VASCULAR PRODUCTS ARE STERILIZED IN BULK AND THERE WERE NO OTHER INCIDENTS REPORTED FROM THIS LOT THAT EXHIBITED THE SAME FAILURE MODE, THIS SUGGESTS THAT THIS DAMAGE IS NOT RELATED TO A QUALITY DEFICIENCY ASSOCIATED WITH THE PRODUCT. THE ACCOUNT LATER CONFIRMED THAT, ETO IS A PROCESS IN WHICH A DEVICE IS RESTERILIZED AND PACKED IF THE CATH LAB WANTS TO RETURN IT OR USE IT LATER. THE ACCOUNTS STATEMENT OF ETO MAY SUGGEST THAT THE CATHETER WAS PROCESSED THROUGH A POST-USE RESTERILIZATION METHOD, WHICH MAY HAVE CONTRIBUTED TO THE NOTED MARKER DAMAGE; HOWEVER, THIS CANNOT BE CONFIRMED. IT SHOULD BE NOTED THAT THE PRODUCTS INSTRUCTIONS FOR USE (IFU) STATES, THIS DEVICE IS INTENDED FOR ONE TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE IT, AS THIS CAN COMPROMISE DEVICE PERFORMANCE AND INCREASE RISK OF CROSS CONTAMINATION DUE TO INAPPROPRIATE REPROCESSING. THE ANALYSIS NOTED A KINK IN THE HYPOTUBE, 39CM DISTAL TO THE STRAIN RELIEF TUBING AND IN THE OUTER MEMBER WHERE THE BAYONET WAS SEPARATED IN THE SAME LOCATION, 9.5CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT ORIGINALLY REPORTED, THE SHAFT LIKELY KINKED FROM FURTHER HANDLING AFTER THE PROCEDURE AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE ANALYSIS OF THE RETURNED PRODUCT, THE REPORTED DIFFICULTY TO POSITION/VISUALIZE THE CATHETER APPEARS TO BE RELATED TO THE DISINTEGRATED BALLOON MARKERS. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE DAMAGE TO THE BALLOON MARKERS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ALL DILATATION CATHETERS ARE SUBJECT TO AN INSPECTION ONLINE DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% BLOCK IN THE MID LEFT ANTERIOR DESCENDING ARTERY LESION. THE VESSEL WAS MODERATELY TORTUOUS AND HEAVILY CALCIFIED. THE LESION WAS BEING PREDILATED WITH THE VOYAGER NC 3.0 X 12 MM BALLOON CATHETER; HOWEVER, WHILE TRYING TO ADVANCE THE DEVICE, THE BALLOON MARKERS WERE DIFFICULT TO VISUALIZE TO PLACE THE BALLOON WITHIN THE LESION. ALTHOUGH IT WAS NOT CERTAIN, THE PHYSICIAN MAY HAVE TRIED TO INFLATE THE BALLOON. THE DEVICE WAS REMOVED AND ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS FOUND THE HYPOTUBE AT THE PROXIMAL END WAS SEPARATED AND THE MARKER LUMENS WERE DISINTEGRATED LEAVING LOOSE PARTICLES MIXED WITH THE CONTRAST IN THE BALLOON AND INFLATION LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA 9071461

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DILATATION CATH: VOYAGER 3X12