BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 7942523 · Received October 8, 2018

    Report

    Report Number
    1037905-2018-00474
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE COMMON DEVICE NAME: NOT AVAILABLE REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE INFORMATION REGARDING PMA# DEN170015. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT OF BLOOD IN THE CATHETER WAS CONFIRMED WITH THE PICTURES PROVIDED. THERE IS RED FLUID ASSUMED TO BE BLOOD THROUGHOUT THE LENGTH OF THE CATHETER. AT THE PROXIMAL END OF THE CATHETER, DARK POWDER IS COLLECTED INSIDE THE TUBING. NO KINKS ARE VISIBLE ON THE CATHETERS IN THE PICTURES AND THE REPORT OF KINKING CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. HOWEVER, ADDITIONAL INFORMATION PROVIDED INDICATED THIS OCCURRENCE COULD BE RELATED TO BLOOD FROM THE SURROUNDING AREA CLOGGING THE CATHETER. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER THE INSTRUCTIONS FOR USE STATE THE FOLLOWING, "DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE INSTRUCTIONS FOR USE ALSO STATE: "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL." THE INSTRUCTIONS FOR USE STATES: "NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE." DURING SYSTEMS PREPARATIONS THE INSTRUCTIONS FOR USE STATE, "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITIONS, DO NOT USE." THE INSTRUCTIONS FOR USE STATE: "SLOWLY ADVANCE CATHETER THROUGH ACCESSORY CHANNEL IN SHORT INCREMENTS UNTIL CATHETER TIP IS VISUALLY ENDOSCOPICALLY." ADVANCING THE CATHETER SLOWLY IN SHORT INCREMENTS WILL AID IN PRESERVATION OF THE DEVICE. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE USER TOUCHED THE CATHETERS TO THE BLEEDING SITE, 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 A COLONIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE FIRST TIME USING IT [HEMOSPRAY], THE USER PASSED THE CATHETER [THROUGH THE ENDOSCOPE] AND BLOOD WICKED UP [SIC] THE FIRST CATHETER AND CLOGGED. AFTER IT CLOGGED THE FIRST ONE, THEY ATTEMPTED TO PUT IT DOWN THE SECOND CATHETER AND AGAIN GOT NO SPRAY. THEY PULLED THE SECOND CATHETER OUT AND SAW THAT IT WAS KINKED. AT THAT POINT, THEY GAVE UP ON HEMOSPRAY AND USED HEMOCLIPS. THE FOLLOWING WAS REPORTED WITH THE PHOTOS PROVIDED BY THE COOK AREA SALES REPRESENTATIVE ON 14-SEPT-2018: YOU CAN SEE THE ONE CATHETER WITH BLOOD IN IT THAT CLOGGED, AND THE OTHER CATHETER WITHOUT THE BLOOD IS THE ONE THAT KINKED, THOUGH I CAN¿T REALLY SEE THE KINK IN THE PICTURE. AN UNINTENDED 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
    784388 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1