BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2211921 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05738
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND HANDLING. THE BALLOON WAS TIGHTLY FOLDED. THE OUTER MEMBER WAS NECKED AT THE DISTAL END OF THE LAP JOINT FOR A LENGTH OF .5 MM. DIFFICULTY INFLATING THE BALLOON CAN BE AFFECTED BY, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE WHEN USING THE PRODUCT AND ACCESSORY DEVICE SUPPORT, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED AND BLOCKING THE FLOW OF CONTRAST IN OR OUT OF THE BALLOON, AND/OR CONTAMINATION IN THE INFLATION LUMEN AND INNER DIAMETER OF THE SHAFT. A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER; HOWEVER THE BALLOON DID NOT INFLATE. THE FLUID DID NOT ADVANCE PAST THE NECKED OUTER MEMBER. 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 DIFFICULTIES 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. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY INFLATING THE BALLOON APPEARS TO BE RELATED TO THE STRETCHED SHAFT; HOWEVER, A CONCLUSIVE CAUSE FOR THE STRETCHED AND DAMAGED SHAFT COULD NOT BE DETERMINED 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

    REPORTEDLY DURING USE OF THE DEVICE FOR POST DILATATION OF A XIENCE V STENT IN THE LEFT ANTERIOR DESCENDING ARTERY, WITH NO TORTUOSITY OR CALCIFICATION, THE VOYAGER NC WOULD NOT INFLATE. THE VOYAGER NC WAS WITHDRAWN WITHOUT FURTHER INCIDENT AND A TREK WAS SUCCESSFULLY USED. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 1021561

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR STENT: XIENCE