BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT® 2 CALIBRATED TIP WIRE GUIDE

    MDR report key: 7139058 · Received December 21, 2017

    Report

    Report Number
    1037905-2017-00764
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 21, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    OCY
    UDI-DI
    00827002476141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: COOK FUSION OMNI-TOME SPHINCTEROTOME, FS-OMNI, COOK FUSION QUATTRO EXTRACTION BALLOON, FS-QEB-XL-A. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO DO THE FOLLOWING: "PRIOR TO REMOVING WIRE GUIDE FROM HOLDER, FLUSH WITH 30 CC OF STERILE WATER." FAILURE TO FLUSH THE WIRE GUIDE CAN RESULT IN DAMAGE TO THE WIRE GUIDE. PRIOR TO DISTRIBUTION, ALL ACROBAT 2 CALIBRATED TIP WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO 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: 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THIS CASE WAS WITH A PATIENT WITH DOWN SYNDROME AND A LITTLE ABNORMAL ANATOMY. THE USER PLACED A WIRE GUIDE WITH A COOK FUSION OMNI SPHINCTEROTOME (FS-OMNI). CONTRAST WAS USED. WHEN SPLITTING, A LOOP ON THE WIRE LOCK FORMED ONCE. THEN, WHEN USING THE COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-XL-A), IT HAPPENED ONCE AGAIN. CONTRAST USED AGAIN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12/11/17: WIRE GUIDE ACCESS TO THE COMMON BILE DUCT WAS LOST DURING THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919179 ACROBAT® 2 CALIBRATED TIP WIRE GUIDE OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY COOK ENDOSCOPY G47614 00827002476141

    Patients

    Seq Age Sex Outcome Treatment
    1