BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2061635 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02718
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 PRODUCT FOUND BLOOD AND CONTRAST VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE DISTAL SHAFT, CONSISTENT WITH HANDLING. THE BALLOON WAS TIGHTLY FOLDED. THE REPORTED INFLATION DIFFICULTIES COULD NOT BE CONFIRMED AS A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER TO THE RATED BALLOON PRESSURE (RBP) AND THE BALLOON INFLATED AND HELD PRESSURE. THE PATIENT ANATOMICAL INFORMATION WAS NOT PROVIDED WITH THE CASE INFORMATION; HOWEVER, IF THE ANATOMY WAS HEAVILY TORTUOUS OR CALCIFIED, IT COULD POTENTIALLY CAUSE THE INFLATION LUMEN TO NARROW; RESULTING IN DIFFICULTY INFLATING THE BALLOON; HOWEVER THIS COULD NOT BE CONFIRMED. TO HELP ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, VARIOUS QUALITY CHECKS ARE IN PLACE TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION. 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 SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES FOR THIS LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOYAGER NC BALLOON CATHETER DID NOT DILATE WHEN THE PRESSURE REACHED THE RATED BALLOON PRESSURE (RBP). NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL 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 0063061

    Patients

    Seq Age Sex Outcome Treatment
    1