BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON-COOK ACHALASIA BALLOON

    MDR report key: 10636533 · Received October 6, 2020

    Report

    Report Number
    1037905-2020-00424
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    August 14, 2020
    Report Date
    October 5, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PID
    UDI-DI
    10827002248936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: PID. COMMON NAME: ESOPHAGEAL DILATOR BALLOON WITH OT WITHOUT ELECTRODE SENSORS. PMA/510(K) #: K182895. OCCUPATION - NON-HEALTH CARE PROFESSIONAL . INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH A CLEAR LIQUID INSIDE OF THE BALLOON AND A BEND/KINK IN THE CATHETER AT 55.6CM DISTAL FROM THE HANDLE. THE BALLOON WAS INFLATED WITH AIR AND IT WAS NOTED THE LIQUID INSIDE THE BALLOON WAS LEAKING FROM A HOLE IN THE MIDDLE OF THE BALLOON. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BALLOON WAS INFLATED WITH STERILE WATER. THE INSTRUCTIONS FOR USE STATE: "INFLATE THE BALLOON WITH AIR ONLY. NOTE: INFLATING WITH LIQUID CAN INCREASE THE RISK OF BALLOON DAMAGE, ASPIRATION AND/OR PERFORATION." THIS IS THE MOST LIKELY CAUSE OF THE EVENT. PRIOR TO DISTRIBUTION, ALL WILSON-COOK ACHALASIA BALLOON ARE SUBJECTED TO A VISUAL INSPECTION ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL INFORMATION REGARDING IN-SERVICE: BASED ON THE INFORMATION PROVIDED THAT THE BALLOON WAS INFLATED WITH STERILE WATER, A COOK REPRESENTATIVE 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 AN ACHALASIA DILATION, THE PHYSICIAN USED A WILSON-COOK ACHALASIA BALLOON. ON 17-AUG-2020 IT WAS REPORTED THAT THE BALLOON LEAKED. ON 15-SEP-2020 CLARIFICATION WAS RECEIVED STATING THE DEVICE WAS INFLATED WITH STERILE WATER [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097608 WILSON-COOK ACHALASIA BALLOON PID COOK ENDOSCOPY W4342408 10827002248936

    Patients

    Seq Age Sex Outcome Treatment
    1