BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-HUIBREGTSE BILIARY STENT

    MDR report key: 15016038 · Received July 14, 2022

    Report

    Report Number
    1037905-2022-00385
    Event Type
    Injury
    Date Received
    July 14, 2022
    Report Date
    August 8, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ARTICLE IS UNDER INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. KHASHAB MA, HUTFLESS S, KIM K, LENNON AM, CANTO MI, JAGANNATH SB, OKOLO PI 3RD, SHIN EJ, SINGH VK. A COMPARATIVE EVALUATION OF EARLY STENT OCCLUSION AMONG BILIARY CONVENTIONAL VERSUS WING STENTS. DIG DIS SCI. 2012 JUN;57(6):1708-16. DOI: 10.1007/S10620-012-2048-0. EPUB 2012 JAN 20. PMID: 22262198.

    Additional Manufacturer Narrative · 0

    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. 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. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE PRODUCT LINE FOR CHBSO WAS TRANSFERRED TO COOK IRELAND AND OBSOLETED AT COOK WINSTON SALEM IN 2009. THE IFU WARNS, "THOSE [POTENTIAL COMPLICATIONS] ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION." PRIOR TO DISTRIBUTION, ALL COTTON-HUIBREGTSE BILIARY STENTS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME BECAUSE THE POTENTIAL RPN, CHBSO, WAS OBSOLETED ON 11/19/2009. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. KHASHAB MA, HUTFLESS S, KIM K, LENNON AM, CANTO MI, JAGANNATH SB, OKOLO PI 3RD, SHIN EJ, SINGH VK. A COMPARATIVE EVALUATION OF EARLY STENT OCCLUSION AMONG BILIARY CONVENTIONAL VERSUS WING STENTS. DIG DIS SCI. 2012 JUN;57(6):1708-16. DOI: 10.1007/S10620-012-2048-0. EPUB 2012 JAN 20. PMID: 22262198.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK COTTON-HUIBREGTSE BILIARY STENT. THIS ARTICLE IS UNDER REVIEW AND INVESTIGATION. A FOLLOW UP EMDR WILL BE SENT TO CAPTURE THE PERTINENT INFORMATION AND COMPLETED INVESTIGATION. PLEASE NOTE THAT SEPARATE REPORTS TO FURTHER CAPTURE THE DIFFERENT EVENTS MAY BE SUBMITTED BASED ON THE OUTCOME OF THE INVESTIGATION. KHASHAB MA, HUTFLESS S, KIM K, LENNON AM, CANTO MI, JAGANNATH SB, OKOLO PI 3RD, SHIN EJ, SINGH VK. A COMPARATIVE EVALUATION OF EARLY STENT OCCLUSION AMONG BILIARY CONVENTIONAL VERSUS WING STENTS. DIG DIS SCI. 2012 JUN;57(6):1708-16. DOI: 10.1007/S10620-012-2048-0. EPUB 2012 JAN 20. PMID: 22262198.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK COTTON-HUIBREGTSE BILIARY STENT. SEE RELEVANT EXCERPTS: "THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE INCIDENCE OF EARLY STENT OCCLUSION (SYMPTOMATIC OCCLUSION/CHOLANGITIS NECESSITATING RE-INSERTION WITHIN 90 DAYS) FROM 2003-2009. MOST OF THE CONVENTIONAL STENTS USED WERE 7 AND 10 FR COTTON¿HUIBREGTSE BILIARY STENTS (CHBS) (COOK MEDICAL, WINSTON-SALEM, NC, USA). PATIENTS WHO UNDERWENT ONLY CONVENTIONAL PLASTIC STENT PLACEMENT COMPRISED THE CONVENTIONAL STENT GROUP (CONVENTIONAL GROUP). DEFINITION OF EARLY STENT OCCLUSION: IF PATIENTS PRESENTED WITH SIGNS AND/OR SYMPTOMS OF STENT OCCLUSION (CHOLANGITIS, RECURRENT JAUNDICE, WORSENING CHOLESTASIS) BEFORE THEIR SCHEDULED ERCP, ERCP WAS PERFORMED TO CONFIRM EARLY OCCLUSION OF THE STENT, EXCLUDE OTHER CAUSES OF CHOLESTASIS, AND STENT EXCHANGE WAS PERFORMED WHEN INDICATED. IN THIS STUDY, EARLY STENT OCCLUSION OCCURRED IN 112 (18.3%) PROCEDURES, WHICH REQUIRED THE PERFORMANCE OF UNSCHEDULED ERCP IN ALL CASES. THE PRESENTING SYMPTOM WAS CHOLANGITIS IN 39 (34.8%) PATIENTS. OF THE 537 PATIENTS IN THE CONVENTIONAL GROUP, 89 (16.6%) REQUIRED UNSCHEDULED BILIARY STENT CHANGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464203 COTTON-HUIBREGTSE BILIARY STENT FGE, BILIARY CATHETER AND ACCESSORIES FGE WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SCOPE UNKNOWN MAKE AND MODEL