BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3E DIRECT ACCESS MEDICAL

    MDR report key: 2132245 · Received June 1, 2011

    Report

    Report Number
    3005994106-2011-00003
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 23, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CREAGH MEDICAL LTD
    Product Code
    DQY
    PMA / PMN Number
    K102645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH HISTORY RECORD FOR THE DEVICE WAS REVIEWED. THE BATCH MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE HAS BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION IS IN PROGRESS. THE CATHETER WAS RE-INSERTED AND INFLATED AT LEAST 5 TIMES.

    Additional Manufacturer Narrative · 1

    THE UHP 8X4 CATHETER COULD NOT BE REMOVED FROM 7FR MERIT SHEATH AFTER REINSERTION. THE CATHETER AND SHEATH HAD TO BE REMOVED COMPLETELY AND AN 8FR SHEATH WAS USED. AFTER FURTHER INSPECTION OF THE BALLOON, THE BALLOON WAS "BUNCHED" AT THE DISTAL TIP OF THE SHEATH AND COULD NOT BE REMOVED THROUGH THE SHEATH. REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT 11000118 REVEALED NO ANOMALIES DURING MANUFACTURE. MANUFACTURING CONTROLS ARE IN PLACE TO ENSURE THAT THE BALLOON IS MANUFACTURED TO SPECIFICATION. PRODUCT IS 100% VISUALLY INSPECTED FOR DEFECTS. THE INTEGRITY OF THE BALLOON IS INSPECTED PRIOR TO RELEASE, BY WAY OF A LEAK TEST FOR EACH UNIT IN THE BATCH, INCORPORATING INFLATION UP TO RATED BURST PRESSURE. THE COMPLAINT INVESTIGATION OUTCOME, IN THIS CASE, IS INCONCLUSIVE. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED, AS THE REPORTED COMPLAINT TYPE COULD NOT BE REPLICATED AFTER REMOVAL, REINFLATION, DEFLATION AND REPEAT REMOVAL OF THE CATHETER THROUGH THE SAME INTRODUCER.

    Description of Event or Problem · 1

    THE UHP 8X40 CATHETER COULD NOT BE REMOVED FROM 7FR MERIT SHEATH AFTER REINSERTION. THE CATHETER AND SHEATH HAD TO E REMOVED COMPLETELY. AFTER FURTHER INSPECTION OF THE BALLOON, THE BALLOON WAS "BUNCHED" AT THE DISTAL TIP OF THE SHEATH AND COULD NOT BE REMOVED THROUGH THE SHEATH.

    Description of Event or Problem · 1

    THE UHP 8X4 CATHETER COULD NOT BE REMOVED FROM 7FR MERIT SHEATH AFTER REINSERTION. THE CATHETER AND SHEATH HAD TO BE REMOVED COMPLETELY. AFTER FURTHER INSPECTION OF THE BALLOON, THE BALLOON WAS "BUNCHED" AT THE DISTAL TIP OF THE SHEATH AND COULD NOT BE REMOVED THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3E DIRECT ACCESS MEDICAL ELM HP 8 X 40CM BALLOON CATHETER DQY CREAGH MEDICAL LTD ELM 8 X 40 11000118

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention