BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 15015049 · Received July 14, 2022

    Report

    Report Number
    1037905-2022-00382
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    July 1, 2002
    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
    CH
    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. LEE DW, CHAN AC, LAM YH, NG EK, LAU JY, LAW BK, LAI CW, SUNG JJ, CHUNG SC. BILIARY DECOMPRESSION BY NASOBILIARY CATHETER OR BILIARY STENT IN ACUTE SUPPURATIVE CHOLANGITIS: A PROSPECTIVE RANDOMIZED TRIAL. GASTROINTEST ENDOSC. 2002 SEP;56(3):361-5. DOI: 10.1016/S0016-5107(02)70039-4. PMID: 12196773.

    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 CLSO WAS TRANSFERRED TO COOK IRELAND AND OBSOLETED AT COOK WINSTON SALEM IN 2010. 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-LEUNG 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, CLSO, WAS OBSOLETED ON 6/25/2010. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. LEE DW, CHAN AC, LAM YH, NG EK, LAU JY, LAW BK, LAI CW, SUNG JJ, CHUNG SC. BILIARY DECOMPRESSION BY NASOBILIARY CATHETER OR BILIARY STENT IN ACUTE SUPPURATIVE CHOLANGITIS: A PROSPECTIVE RANDOMIZED TRIAL. GASTROINTEST ENDOSC. 2002 SEP;56(3):361-5. DOI: 10.1016/S0016-5107(02)70039-4. PMID: 12196773.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK COTTON-LEUNG 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. LEE DW, CHAN AC, LAM YH, NG EK, LAU JY, LAW BK, LAI CW, SUNG JJ, CHUNG SC. BILIARY DECOMPRESSION BY NASOBILIARY CATHETER OR BILIARY STENT IN ACUTE SUPPURATIVE CHOLANGITIS: A PROSPECTIVE RANDOMIZED TRIAL. GASTROINTEST ENDOSC. 2002 SEP;56(3):361-5. DOI: 10.1016/S0016-5107(02)70039-4. PMID: 12196773.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE CLINICAL LITERATURE ARTICLE INVOLVING COOK COTTON-LEUNG BILIARY STENT. SEE RELEVANT EXCERPTS: "MAY 1994 TO MAY 1999 AFTER SUCCESSFUL BILE DUCT CANNULATION, PATIENTS WERE RANDOMIZED TO RECEIVE EITHER A NASOBILIARY CATHETER OR INDWELLING STENT WITHOUT SPHINCTEROTOMY FOR BILIARY DECOMPRESSION. FOUR PATIENTS PULLED OUT THE NASOBILIARY CATHETER AND ONE CATHETER BECAME KINKED. ONE STENT OCCLUDED. THE SPECIFICATIONS OF THE NBC USED WERE AS FOLLOWS: 6.5F, 7 SIDE HOLES, AND RIGHT ANGLE BEND TIP WITH PREFORMED DUODENAL LOOP (LEUNG NASAL BILIARY DRAINAGE CATHETER, WILSON COOK MEDICAL, INC., WINSTON-SALEM, N.C.). THE SPECIFICATIONS FOR THE STENT WERE 10F, ONE SIDE HOLE, AND STRAIGHT PLASTIC (COTTON-LEUNG BILIARY STENT, WILSON COOK). THE END POINT OF THE STUDY WAS DEFINED AS 24 HOURS AFTER THE PROCEDURE AT WHICH TIME THE OUTCOME MEASURES WERE ASSESSED. 40 PATIENTS WERE RANDOMIZED TO THE NBC GROUP AND 34 TO THE STENT GROUP ONE PATIENT IN THE NBC GROUP HAD PANCREATITIS DEVELOP (REFERENCE), WHICH RESOLVED WITH CONSERVATIVE TREATMENT. THERE WAS NO ERCP-RELATED COMPLICATION IN THE STENT GROUP. FOUR PATIENTS PULLED OUT THE NBC AND THE NBC BECAME KINKED IN ONE. THE STENT BECAME OCCLUDED IN ONE PATIENT WHO HAD PURULENT BILE AT THE FIRST ERCP AND AFTER THE DRAINAGE PROCEDURE HAD PERSISTENT FEVER WITH AN INCREASING SERUM BILIRUBIN LEVEL [SUBJECT OF THIS REPORT]. THESE 6 PATIENTS ALL UNDERWENT AN UNSCHEDULED, EARLY SECOND ERCP TO TREAT THE CHOLANGITIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908329 COTTON-LEUNG 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