BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2182669 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05356
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE BALLOON WAS TIGHTLY FOLDED. THE SHAFT WAS STRETCHED (NECKED) DISTAL TO THE GUIDE WIRE EXIT NOTCH. FACTORS THAT COULD HAVE CONTRIBUTED TO DIFFICULTY INFLATING THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, CONTRAST CONCENTRATION, BALLOON MATERIALS, MANUFACTURING, INFLATION LUMEN OBSTRUCTION, INTERACTION WITH ACCESSORIES (INDEFLATOR, ROTATING HEMOSTATIC VALVE, OR GUIDING CATHETER), PLACEMENT OF THE BALLOON WITHIN LESION, OR INFLATION TECHNIQUE. A NEW INDEFLATOR WAS FILLED WITH CONTRAST MEDIUM; DILUTED 1:1 WITH COLORED WATER AND WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP). THE BALLOON INFLATED TO RBP WITH NO ANOMALIES NOTED. THE REPORTED INFLATION DIFFICULTY WAS UNABLE TO BE CONFIRMED; THE NEW INDEFLATOR WAS ALSO USED TO MEASURE THE INFLATION TIMES OF THE BALLOON, AND THESE MET MANUFACTURING CRITERIA. REPORTEDLY, NO DAMAGE WAS REPORTED AS BEING OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED DURING THE PROCEDURE. IT IS POSSIBLE THE SHAFT WAS INADVERTENTLY HANDLED DURING THE PREPARATION FOR USE, RESULTING IN THE STRETCHING NOTED TO THE SHAFT. HOWEVER, PER DEVICE ANALYSIS THE SHAFT STRETCHING DOES NOT APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY INFLATING THE BALLOON. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTY INFLATING THE BALLOON WAS UNABLE TO BE CONFIRMED AND 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

    IT WAS REPORTED THAT, DURING A PROCEDURE OF THE MILDLY CALCIFIED, MILDLY TORTUOUS VESSEL, THE VOYAGER NC WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A SECOND DEVICE WAS USED IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION 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 1021461

    Patients

    Seq Age Sex Outcome Treatment
    1