BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2200404 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05668
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED CATHETER NOTED THE SOFT TIP WAS TORN ALMOST COMPLETELY AT THE DISTAL SEAL, BUT WAS STILL INTACT. FOLLOW UP INFORMATION RECEIVED FROM THE ACCOUNT CONFIRMED THAT THE TIP WAS ONLY NOTED TO BE BENT, NOT TORN; THEREFORE, IT IS LIKELY THAT ADDITIONAL HANDLING DURING PACKING FOR RETURN ANALYSIS CONTRIBUTED TO FURTHER DAMAGING THE TIP AT THE BEND LOCATION RESULTING IN THE NOTED TEAR. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMANCE THAT APPEARS TO HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH PREPARATION. THE BALLOON WAS TIGHTLY FOLDED. THE SOFT TIP WAS TORN ALMOST COMPLETELY OFF AT THE DISTAL SEAL, BUT WAS STILL INTACT. TEARS IN THE TIP CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO: MANUFACTURING (PROCESSING AND/OR HANDLING), HANDLING DURING REMOVAL FROM PACKAGING AT THE ACCOUNT, PREPARATION/USE OF THE CATHETER, OR INTERACTION WITH LESION/ANATOMY OR ACCESSORY DEVICES. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE TIP TENSILE FORCE. A CONCLUSIVE CAUSE FOR THE REPORTED BEND IN THE TIP COULD NOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE NC VOYAGER BALLOON CATHETER WAS BENT OUT OF THE PACKAGE. THE DEVICE WAS THEREFORE REPLACED WITH A SAME-SIZED VOYAGER CATHETER TO CONTINUE WITH THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. RETURNED DEVICE ANALYSIS REVEALED THAT THE SOFT TIP WAS NEARLY SEPARATED. FURTHER COMMUNICATION WITH THE SITE RE-ITERATED THAT THE TIP WAS ONLY BENT WHEN IT WAS REMOVED FROM THE PACKAGE. 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 1042261

    Patients

    Seq Age Sex Outcome Treatment
    1