BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2181781 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05331
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED BLOOD VISIBLE ON THE BALLOON, HUB, THE NON-ABBOTT GUIDING CATHETER AND CONTRAST IN THE BALLOON, CONSISTENT WITH PREPARATION AND THE CATHETER ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED AND THE DISTAL END WAS BUNCHED AT THE DISTAL END OF THE NON-ABBOTT GUIDING CATHETER. THERE WAS A BEND IN THE HYPOTUBE 1 MM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A KINK IN THE HYPOTUBE 11.5 CM DISTAL TO THE STRAIN RELIEF TUBING. A CO-PILOT WAS RETURNED ON THE BALLOON CATHETER AND A NON-ABBOTT EMBOLIC PROTECTION DEVICE WAS RETURNED BACKLOADED THROUGH THE BALLOON CATHETER. THERE WAS A BEND IN THE TIP OF THE EMBOLIC PROTECTION DEVICE. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEFLATING THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. THE TOTAL CATHETER LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON CATHETER FROM THE NON-ABBOTT GUIDING CATHETER, BUT THE CATHETER WAS NOT ABLE TO BE REMOVED. AFTER THE BALLOON CATHETER AND GUIDING CATHETER WERE SOAKED IN THE WATER BATH, AN INDEFLATOR, FILLED WITH WATER, WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) THEN THE BALLOON WAS FULLY DEFLATED AND THE BALLOON CATHETER WAS REMOVED FROM THE GUIDING CATHETER. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS AN INDEFLATOR, FILLED WITH GRASTROGRAFIN DILUTED 1:1 WITH WATER, WAS USED TO MEASURE THE DEFLATION TIMES WHICH MET MANUFACTURING CRITERIA. IT IS POSSIBLE THE BALLOON INTERACTED WITH THE DEPLOYED STENT, CONTRIBUTING TO THE DEFLATION DIFFICULTIES; HOWEVER, THIS COULD NOT BE CONFIRMED. INCIDENTALLY, AS THE NOTED BEND AND KINK TO THE HYPOTUBE DO NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES DEFLATING THE BALLOON, IT IS LIKELY THAT THEY OCCURRED DURING THE PROCEDURE OR DURING PACKING FOR RETURN ANALYSIS. FURTHER, AN INTERACTION WITH THE GUIDING CATHETER DURING THE ATTEMPTS TO REMOVE THE BALLOON LIKELY CONTRIBUTED TO THE NOTED BALLOON BUNCHING. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION AND DEFLATION.

    Description of Event or Problem · 1

    REPORTEDLY THE VOYAGER NC WOULD NOT FULLY DEFLATE AFTER THE SUCCESSFUL POST DILATATION OF A XIENCE V IN THE LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION. THEY TRIED PULLING NEGATIVE; HOWEVER, THIS WAS UNSUCCESSFUL SO THEY TRIED USING A DIFFERENT INDEFLATOR WHICH WAS ALSO UNSUCCESSFUL. AT THIS POINT ALL OF THE DEVICES WERE WITHDRAWN AS ONE UNIT WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS REPORTEDLY OCCURRED. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1051661

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE V