BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2060380 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02687
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE ON THE SHAFT, CONSISTENT WITH HANDLING. THE BALLOON WAS TIGHTLY FOLDED. THE TIP WAS SEPARATED AT THE DISTAL END OF THE DISTAL SEAL AND WAS NOT RETURNED. THE MATERIAL AT THE SEPARATION WAS STRETCHED AND JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE CROSSING PROFILE, 2/3 COLLAPSED PROFILE AND INNER DIAMETER OF THE GUIDE WIRE LUMEN WERE MEASURED AND MET MANUFACTURING CRITERIA. FACTORS THAT CAN CONTRIBUTE TO TIP DETACHMENT INCLUDE BUT ARE NOT LIMITED TO MANUFACTURING, REMOVAL FROM PACKAGING AT THE ACCOUNT, HANDLING DURING PREPARATION/USE, OR INSERTION OF THE GUIDE WIRE. IT IS POSSIBLE THE TIP WAS INADVERTENTLY HANDLED DURING PREPARATION; HOWEVER THIS COULD NOT BE CONFIRMED. 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 HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE TIP DETACHMENT COULD NOT BE DETERMINED. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR TIP DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY TIP PULL FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. THE RETURNED DEVICE REVEALED THAT THE TIP OF THE BALLOON WAS NOTED TO BE SEPARATED. BASED ON THE RETURNED DEVICE EVALUATION, THE DEVICE DOES NOT APPEAR TO HAVE BEEN USED IN THE PATIENT'S ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092361

    Patients

    Seq Age Sex Outcome Treatment
    1