BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE VARICES INJECTOR (DEVICE 2 OF 2)

    MDR report key: 2212445 · Received March 12, 2008

    Report

    Report Number
    1037905-2008-00025
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 11, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    GAA
    PMA / PMN Number
    K851952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED NEEDLE INJECTORS (DEVICES 1 AND 2) CONFIRMED THE REPORT OF NEEDLE PENETRATION OF THE OUTER CATHETER. FOR BOTH DEVICES, A SMALL HOLE WAS DETECTED WHERE THE NEEDLE HAS PENETRATED THE OUTER CATHETER. THE SMALL HOLE IS LOCATED IN THE BLACK SECTION OF THE CATHETERS NEAR THE DISTAL END. THE INJECTOR HANDLES WERE RETURNED IN THE FULLY ADVANCED POSITION; THE INJECTOR HANDLES' POSITION CORRESPONDS TO FULL NEEDLE EXTENSION. DURING OUR LABORATORY ANALYSIS, THE INJECTOR HANDLES WERE RETRACTED AND THE NEEDLES WERE VISUALIZED INSIDE THE DISTAL END OF THE OUTER CATHETERS. THE CATHETER OF THE INJECTOR DEVICES WAS PLACED IN A STRAIGHT POSITION. WHEN THE HANDLES ARE MANIPULATED, THE NEEDLES EXTEND AND RETRACT PROPERLY. BOTH INJECTOR DEVICES HAVE KINKS IN THE OUTER CATHETER. THE OUTER CATHETERS MEASURE WITHIN THE APPROPRIATE SPECIFICATION. A PRODUCT DISCREPANCY THAT COULD HAVE CONTRIBUTED TO NEEDLE PENETRATION OF THE OUTER SHEATH WAS NOT OBSERVED DURING OUR LAB ANALYSIS. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF NEEDLE PENETRATION OF THE OUTER SHEATH IS RARE. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE CANNOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. WHILE CLINICAL CONDITIONS ARE NOT THE SOLE DETERMINING FACTORS, THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE THE CAUSE FOR THIS OBSERVATION. HOWEVER, WE CAN PROVIDE THE FOLLOWING COMMENTS: THE INSTRUCTIONS FOR USE INDICATE ASPIRATION IS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. NEEDLE PENETRATION OF THE OUTER CATHETER CAN OCCUR IF NEEDLE EXTENSION IS ATTEMPTED WITH THE CATHETER IN A COILED OR CURVED POSITION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO UNCOIL THE CATHETER AND STRAIGHTEN COMPLETELY. THE INSTRUCTIONS FOR USE ALSO CAUTION THE USER THAT ADVANCING THE NEEDLE WHILE THE CATHETER IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE DEVICE. KINKS IN THE OUTER CATHETER CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE AND/OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ADVANCE THE DEVICE THROUGH THE ACCESSORY CHANNEL IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL DISPOSABLE VARICES INJECTORS ARE SUBJECTED TO A FUNCTIONAL TEST TO ENSURE APPROPRIATE NEEDLE EXTENSION AND A VISUAL INSPECTION TO ENSURE THE PRODUCT IS FREE OF KINKS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THESE LOTS MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE THE PHYSICIAN ATTEMPTED TO USE A COOK ENDOSCOPY DISPOSABLE VARICES INJECTOR (DEVICE 1 OF 2) FOR AN INJECTION OF BOTOX INTO THE PYLORUS OF THE STOMACH. THE INJECTOR DEVICE WAS ADVANCED INTO POSITION AND NEEDLE EXTENSION FROM THE OUTER CATHETER WAS ATTEMPTED. INSTEAD OF EXTENDING FROM THE END OF THE OUTER CATHETER, THE NEEDLE PENETRATED THE SIDE OF THE OUTER CATHETER. THE INJECTOR DEVICE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO USE A SECOND COOK ENDOSCOPY DISPOSABLE VARICES INJECTOR (DEVICE 2 OF 2). THE NEEDLE OF THE SECOND INJECTOR DEVICE YIELDED THE SAME RESULTS AS THE FIRST INJECTION DEVICE; THE NEEDLE PENETRATED THE OUTER CATHETER. THE INJECTOR DEVICE WAS REMOVED AND A THIRD VARICES INJECTOR WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. THE INITIAL REPORTER INDICATED THAT DUE TO THE LENGTH OF THE PROCEDURE (INJECTOR DEVICES CONTRIBUTED TO A DELAY) AND THE POSITION OF THE PT, THE PT ASPIRATED AND WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). THE PT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE. FOR SUSPECT MEDICAL DEVICE INFO ON DEVICE 1 OF 2, SEE REPORT NUMBER 1037905-2008-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE VARICES INJECTOR (DEVICE 2 OF 2) GAA NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA COOK ENDOSCOPY NA W2467795

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization