BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-HUIBREGTSE BILIARY STENT

    MDR report key: 15016196 · Received July 14, 2022

    Report

    Report Number
    1037905-2022-00386
    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, KIM K, HUTFLESS S, LENNON AM, KALLOO AN, SINGH VK. PREDICTORS OF EARLY STENT OCCLUSION AMONG PLASTIC BILIARY STENTS. DIG DIS SCI. 2012 SEP;57(9):2446-50. DOI: 10.1007/S10620-012-2178-4. EPUB 2012 MAY 10. PMID: 22573343.

    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 OBSOLETE 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 OBSOLETE ON 11/19/2009. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. KHASHAB MA, KIM K, HUTFLESS S, LENNON AM, KALLOO AN, SINGH VK. PREDICTORS OF EARLY STENT OCCLUSION AMONG PLASTIC BILIARY STENTS. DIG DIS SCI. 2012 SEP;57(9):2446-50. DOI: 10.1007/S10620-012-2178-4. EPUB 2012 MAY 10. PMID: 22573343.

    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, KIM K, HUTFLESS S, LENNON AM, KALLOO AN, SINGH VK. PREDICTORS OF EARLY STENT OCCLUSION AMONG PLASTIC BILIARY STENTS. DIG DIS SCI. 2012 SEP;57(9):2446-50. DOI: 10.1007/S10620-012-2178-4. EPUB 2012 MAY 10. PMID: 22573343.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK COTTON-HUIBREGTSE BILIARY STENT. SEE RELEVANT EXCERPTS: "JANUARY 2003 AND DECEMBER 2010. THE MAJORITY OF CONVENTIONAL STENTS USED WERE 7 AND 10 FR COTTON¿HUIBREGTSE BILIARY STENTS (COOK MEDICAL, WINSTON-SALEM, NC). IF PATIENTS PRESENTED WITH EARLY STENT OCCLUSION PRIOR TO THEIR SCHEDULED PROCEDURES, ERCP WAS PERFORMED TO CONFIRM EARLY OCCLUSION OF THE STENT, EXCLUDE OTHER CAUSES OF CHOLESTASIS, AND, IF INDICATED, EXCHANGE THE STENT. EARLY STENT OCCLUSION WAS DEFINED AS A WORSENING CHOLESTATIC LIVER TEST RESULTS OF A SEVERITY SUFFICIENTLY SIGNIFICANT TO WARRANT ERCP WITH STENT EXCHANGE PRIOR TO THE PLANNED STENT EXCHANGE, OR AS SYMPTOMS OF CHOLANGITIS. IN THIS STUDY, EARLY STENT OCCLUSION OCCURRED IN 73 (13 %) PROCEDURES, ALL OF WHICH RESULTED IN UNSCHEDULED ERCPS HAVING TO BE PERFORMED. THE PRESENTING SYMPTOM WAS CHOLANGITIS IN 44 PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349012 COTTON-HUIBREGTSE BILIARY STENT FGE, BILIARY CATHETER AND ACCESSORIES FGE WILSON-COOK MEDICAL INC

    Patients

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