BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING

    MDR report key: 2875099 · Received December 12, 2012

    Report

    Report Number
    1037905-2012-00678
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    GCA
    PMA / PMN Number
    K040129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. A SYRINGE WAS USED TO TEST THE AIR FLOW THROUGH THE CATHETER. THE SYRINGE WOULD PUSH AIR THROUGH THE CATHETER AND COULD BE SEEN EXITING THE BALLOON SKIVE WHEN IMMERSED IN WATER. A VISUAL INSPECTION OF THE BALLOON SKIVE WAS CONDUCTED AND NO ANOMALIES WERE NOTED WITH THE SKIVE. ALL BANDS WERE PROPERLY LOCATED AND NO MOVEMENT WAS NOTED THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION. WHEN APPLYING NEGATIVE PRESSURE TO PULL AIR BACK THROUGH THE DEVICE THE SYRINGE WOULD NOT FILL WITH AIR INDICATING THERE WAS BLOCKAGE. THE CATHETER WAS INSPECTED BY FEELING ALONG THE ENTIRE LENGTH OF THE DEVICE. THERE WAS A MINOR BEND IN THE CATHETER APPROXIMATELY 20 CM FROM THE HANDLE THAT COULD NOT BE SEEN VISUALLY. TO CHECK IF THE BEND IN THE CATHETER IS THE POTENTIAL PROBLEM THE CATHETER WAS CUT ON THE PROXIMAL SIDE OF THE MINOR BEND. THE SYRINGE WAS USED TO TEST AIR FLOW AGAIN AND WOULD PUSH AIR THROUGH AND PULL AIR BACK INDICATING THAT THE BLOCKAGE IN THE CATHETER WAS ON THE DISTAL SIDE OF WHERE THE CATHETER WAS SEPARATED. THE SMALL BEND IN THE CATHETER COULD BE PASSING AIR IN ONE DIRECTION BUT COLLAPSING WHEN NEGATIVE PRESSURE IS APPLIED IN THE OTHER DIRECTION. THE CONDITION OF THE RETURNED DEVICE PROHIBITED A FULL EVAL. A VISUAL EXAM DETERMINED THERE WAS A CUT IN THE BALLOON AS INDICATED BY THE USER FACILITY. DUE TO THIS DAMAGE, INFLATION AND DEFLATION OF THE BALLOON COULD NOT BE ATTEMPTED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVAL. ACCORDING TO THE INFO PROVIDED IN THE REPORT THE BALLOON INTEGRITY WAS NOT VERIFIED PRIOR TO USE BY INFLATING THE BALLOON. THE INSTRUCTIONS FOR USE STATES: "VERIFY BALLOON INTEGRITY PRIOR TO USE BY ATTACHING THE ENCLOSED SYRINGE TO STOPCOCK AND INFLATING BALLOON WITH AIR ONLY." PRIOR TO DISTRIBUTION, ALL FUSION EXTRACTION BALLOONS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULT AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFO PROVIDED, A COOK REP HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING A BILIARY STONE EXTRACTION PROCEDURE, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. THE USER WAS ABLE TO SUCCESSFULLY INFLATE THE BALLOON WITH AIR, BUT THE BALLOON WOULD NOT DEFLATE AFTER REMOVAL OF STONES. THE PHYSICIAN CUT THE BALLOON WITH THE ENDOSCOPE AND SUCCESSFULLY REMOVED IT FROM THE PT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS VISIGLIDE 0.035 WIRE GUIDE| OLYMPUS JF-260V ENDOSCOPE