BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKVISTA ACCESS BALLOON PORT 10MMX70MM

    MDR report key: 6070571 · Received November 1, 2016

    Report

    Report Number
    3003898360-2016-01007
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 24, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K112456
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT WECKVISTA ACCESS BALLOON PORT 10MMX70MM, LOT #73F1600379 INVESTIGATIONS DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED 16 UNITS OF 410944 WECKVISTA ACCESS BALLOON PORT 10MMX70MM FOR INVESTIGATION. THERE WERE 16 REPRESENTATIVE SAMPLES THAT WERE RETURNED IN THEIR ORIGINAL PACKAGING. AN ACTUAL SAMPLE WAS NOT RETURNED. THE REPRESENTATIVE SAMPLES WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICES REVEALED THAT THE SAMPLES APPEAR TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. (B)(4). A FUNCTIONAL INSPECTION WAS PERFORMED BY ATTEMPTING TO INFLATE THE BALLOON OF ONE OF THE REPRESENTATIVE SAMPLES THAT WAS RETURNED. A 10 ML SYRINGE THAT COMES IN THE PACKAGE OF THE DEVICE WAS FILLED WITH AIR. THE SYRINGE WAS THEN CONNECTED TO THE CHECK VALVE OF THE PORT AND USING HAND PRESSURE, THE AIR WAS INJECTED. THE BALLOON IMMEDIATELY INFLATED. THE BALLOON WAS LEFT INFLATED FOR 10 MINUTES AND NO LEAKS WERE DETECTED. THE SYRINGE WAS THEN CONNECTED TO THE CHECK VALVE AND THE BALLOON WAS DEFLATED. ANOTHER REPRESENTATIVE SAMPLE WAS TESTED. THE SAME RESULTS WERE FOUND. NO FUNCTIONAL ISSUES WERE FOUND WITH EITHER DEVICE THAT WAS TESTED. THE IFU FOR THIS PRODUCT, L05459, WAS REVIEWED AS A OTHER REMARKS: PART OF THIS COMPLAINT INVESTIGATION. THE IFU INFORMS THE USER "FILL THE PROVIDED SYRINGE WITH 10 CC OF STERILE LIQUID OR 15 CC OF AIR. ATTACH THE SYRINGE TO THE CHECK VALVE AND INFLATE SLOWLY. CAUTION: OVER-INFLATION OF THE BALLOON MAY CAUSE IT TO RUPTURE. NOTE THAT 10 CC OF FLUID OR 15 CC OF AIR WILL COMPLETELY INFLATE THE BALLOON AND FURTHER INFLATION IS UNNECESSARY AND WILL INCREASE THE RISK OF BALLOON RUPTURE." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THERE WERE ONLY REPRESENTATIVE SAMPLES THAT WERE RETURNED AND THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE DEVICES. THE REPORTED COMPLAINT OF "PORTS BURSTING DURING USE" COULD NOT BE CONFIRMED SINCE THE ACTUAL SAMPLE WAS NOT RETURNED. THE CUSTOMER RETURNED 16 REPRESENTATIVE SAMPLES IN PLACE OF THE ACTUAL SAMPLE THAT RESULTED IN THE COMPLAINT ISSUE. UPON FUNCTIONAL INSPECTION, NO PROBLEMS WERE FOUND AS THE BALLOONS WERE ABLE TO PROPERLY INFLATE AND DEFLATE FOR BOTH SAMPLES THAT WERE TESTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE PROBABLE CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED WITHOUT THE ACTUAL DEVICE. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IN APPROXIMATELY A TEN DAY PERIOD THE CUSTOMER HAS HAD AT LEAST SIX PORTS THAT BURST DURING USE. THE ADDITIONAL INFORMATION STATED THAT NO PATIENT WAS ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    IN APPROXIMATELY A TEN DAY PERIOD THE CUSTOMER HAS HAD AT LEAST SIX PORTS THAT BURST DURING USE. THE ADDITIONAL INFORMATION STATED THAT NO PATIENT WAS ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719867 WECKVISTA ACCESS BALLOON PORT 10MMX70MM LAPROSCOPE,GENERAL,PLASTIC SURGERY GCJ TELEFLEX MEDICAL 73F1600379

    Patients

    Seq Age Sex Outcome Treatment
    1