BEUDAMED
    FDA Adverse Event Death Summary report: N

    THAL-QUICK ABSCESS DRAINAGE SET

    MDR report key: 6893721 · Received September 26, 2017

    Report

    Report Number
    1820334-2017-03224
    Event Type
    Death
    Date Received
    September 26, 2017
    Report Date
    December 5, 2017
    Manufacturer
    COOK INC
    Product Code
    GBX
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # : EXEMPT. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWING, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION WITH NO ISSUES IDENTIFIED. CLINICAL ASSESSMENT: BASED ON CURRENT INFORMATION, IT IS FEASIBLE TO SUGGEST THE LEADING CAUSES OF THE PATIENT¿S POST-NECROSECTOMY COMPLICATIONS AND SUBSEQUENT DEATH WERE DISEASE PROGRESSION OR MEDICAL PROCEDURE RELATED. THERE IS NO EVIDENCE FROM THE JOURNAL ARTICLE AND THE CURRENT INFORMATION THAT SHOWS ANY CAUSAL RELATIONSHIP BETWEEN THE TQAS-2800-J AND THE PATIENT¿S POST-NECROSECTOMY COMPLICATIONS AND SUBSEQUENT DEATH. THE PRODUCT IS NOT RETURNED AND NO IMAGES ARE PROVIDE TO ASSIST WITH THE INVESTIGATION. THE LOT NUMBER OF THE DEVICE IS NOT PROVIDED. THEREFORE THE MOST RECENT VERSION WAS REVIEWED TO CHECK FOR THE DEVICE SPECIFICATIONS, AS THE WORK ORDER COULD NOT BE OBTAINED. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND IT WAS FOUND THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE IDENTIFIED. DESIGN VERIFICATION AND VALIDATION DOCUMENTS WERE REVIEWED AND LISTS THE BIOCOMPATIBILITY TESTS PERFORMED AND INDICATES THAT THESE DEVICES FULFILL THE INTENDED CLINICAL SAFETY AND PERFORMANCE REQUIREMENTS. EVERY DEVICE IS PROVIDED WITH AN INSTRUCTIONS FOR USE T_TQAS_REV8 WHICH LISTS THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, PROPER PATIENT SELECTION AND TREATMENT, AND PROPER USAGE INSTRUCTIONS. A SEARCH OF THE MANUFACTURER'S DATABASE COULD NOT PERFORMED TO CHECK FOR ASSOCIATED COMPLAINTS IN THE SAME LOT AS THE LOT NUMBER WAS NOT PROVIDED. A SEARCH OF THE MANUFACTURER'S DATABASE FOR THE DEVICE REVEALED THAT THERE IS ANOTHER COMPLAINT (REFERENCE MFR. REPORT: 1820334-2017-03225) ASSOCIATED WITH THE SAME JOURNAL ARTICLE FOR POST-NECROSECTOMY COMPLICATIONS. BASED ON THE INFORMATION PROVIDED, THE LIKELY ROOT CAUSE FOR THE DEATH IS PATIENT CONDITION RELATED, AS IT WAS REPORTED THAT "CAUSE OF THE DEATH WAS INFECTED PANCREATIC NECROSIS". HOWEVER, SINCE THE PATIENT DEATH WAS NOT RELATED TO THE MANUFACTURER'S DEVICE, THIS COMPLAINT CANNOT BE CONFIRMED. IT WAS REPORTED THAT THERE WAS NO SPECIFIC LINK BETWEEN THE DEVICE AND THE DEATH REPORTED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED IN A JOURNAL ARTICLE THAT THE (B)(6) PATIENT, WHO HAD INFECTED PANCREATIC NECROSIS FOR WHICH THEY UNDERWENT A NECROSECTOMY PROCEDURE WHICH MAY HAVE EMPLOYED A THAL-QUICK ABSCESS DRAINAGE SET, SUBSEQUENTLY EXPIRED DUE TO MULTIORGAN FAILURE 50 DAYS POSTOPERATIVELY. THE NECROSECTOMY, WHICH OCCURRED 86 DAYS FROM THE ONSET OF THE PATIENT'S DISEASE, WAS FOLLOWING AN EARLIER FINE NEEDLE ASPIRATION PROCEDURE WHICH DID NOT RESOLVE THE PATIENT'S CONDITION. THE LOT NUMBER OF THE DEVICE WAS UNCONFIRMED IN THE REPORT JOURNAL ARTICLE; ADDITIONALLY, IT IS UNKNOWN IF THE THAL-QUICK ABSCESS DRAINAGE SET WAS THE SPECIFIC PRODUCT ASSOCIATED WITH THE PATIENT EVENT, AS MULTIPLE PRODUCTS FROM SEVERAL DIFFERENT MANUFACTURERS WERE USED IN THIS STUDY. IT WAS NOTED N THE ARTICLE THAT THE PATIENT REQUIRED CONTINUOUS VENOVENOUS HEMODIAFILTRATION AND MECHANICAL VENTILATION THROUGHOUT THE COURSE OF THEIR DISEASE. THE CONDITIONS SURROUNDING THE HANDLING AND USAGE OF THE DEVICE IN THIS CASE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE AUTHOR CLARIFIED THERE WAS NO SPECIFIC LINK BETWEEN THE MANUFACTURER'S DEVICE AND THE PATIENT'S DEATH. FURTHERMORE, THE CAUSE OF DEATH WAS IDENTIFIED AS INFECTED PANCREATIC NECROSIS. NO AUTOPSY WAS PERFORMED. AT THE TIME OF THE EVENT, THE DEVICE WAS NOT BEING REPLACED OVER A PREVIOUS DEVICE. MEDICAL RECORDS ARE NOT AVAILABLE TO SHARE WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673381 THAL-QUICK ABSCESS DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O