BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15198153 · Received August 10, 2022

    Report

    Report Number
    3001845648-2022-00507
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    January 25, 2013
    Report Date
    May 12, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THE 11X DEVICES OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE JOURNAL ARTICLE "BILIARY SPHINCTEROTOMY IS NOT REQUIRED FOR BILE DUCT STENT PLACEMENT" TO CAPTURE CHOLANGITIS AND MODERATE PANCREATITIS. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. CHOLANGITIS AND PANCREATITIS ARE BOTH KNOWN RISKS ASSOCIATED WITH ERCP AS PER THE IFU: "THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. AN IMAGE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PROCEDURE AS BOTH CHOLANGITIS AND PANCREATITIS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH ERCP AS PER THE IFU. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THERE WERE 08 CASES OF MODERATE PANCREATITIS AND 03 CASES OF CHOLANGITIS. THE PATIENT TREATMENT AND OUTCOME ARE UNKNOWN. ACCORDING TO THE MEDICAL ADVISOR¿S INPUT, BOTH THE PANCREATITIS AND CHOLANGITIS WOULD REQUIRE INTERVENTION/ADDITIONAL PROCEDURES AS A RESULT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    WILCOX ET AL 2013 ¿ ¿BILIARY SPHINCTEROTOMY IS NOT REQUIRED FOR BILE DUCT STENT PLACEMENT¿. DURING THIS STUDY PERIOD, OUR PRACTICE HAS BEEN TO ROUTINELY PLACE A SINGLE 7 OR 10 FR PLASTIC (COOK INC., WINSTON SALEM, NC, USA) OR METAL STENT. DURING THIS TIME, THREE EXPERIENCED THERAPEUTIC ENDOSCOPISTS PLACED THESE STENTS. IN GENERAL, SEMS WERE PLACED IN PATIENTS WITH LOCALLY ADVANCED MALIGNANT DISEASE WITH GOOD FUNCTIONAL STATUS. WE PREFER PLACEMENT OF 10-FR BILIARY PLASTIC STENTS IN ALL PATIENTS EXCEPT CHILDREN AND THOSE WITH SMALL BILE LEAKS. SPHINCTEROTOMY WAS DONE USING AN ERBE GENERATOR (ERBE USA, MOULTON, GA, USA) USING THE ENDOCUT FEATURE. ALL COMPLICATIONS WERE ASSESSED PROSPECTIVELY WITH FOLLOW UP AT 24¿48 H AND 1 MONTH BY AN EXPERIENCED NURSE TO CHECK FOR COMPLICATIONS THAT WERE RECORDED USING CONSENSUS CRITERIA. PANCREATITIS (25): OF THE PATIENTS WITH PANCREATITIS, IT WAS FOUND TO BE MILD IN 17 AND MODERATE IN EIGHT PATIENTS. CHOLANGITIS (3).

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP CORRECTION REPORT IS BEING SUBMITTED BASED ON CLINICAL INPUT RECEIVED ON THE 27-MAR-23 AND UPDATE OF THE DESCRIPTION OF EVENT AS FOLLOWS : UPDATED COMPLAINT DESCRIPTION: WILCOX ET AL 2013 ¿ ¿BILIARY SPHINCTEROTOMY IS NOT REQUIRED FOR BILE DUCT STENT PLACEMENT¿. DURING THIS STUDY PERIOD, OUR PRACTICE HAS BEEN TO ROUTINELY PLACE A SINGLE 7 OR 10 FR PLASTIC (COOK INC., WINSTON SALEM, NC, USA) OR METAL STENT. DURING THIS TIME, THREE EXPERIENCED THERAPEUTIC ENDOSCOPISTS PLACED THESE STENTS. IN GENERAL, SEMS WERE PLACED IN PATIENTS WITH LOCALLY ADVANCED MALIGNANT DISEASE WITH GOOD FUNCTIONAL STATUS. WE PREFER PLACEMENT OF 10-FR BILIARY PLASTIC STENTS IN ALL PATIENTS EXCEPT CHILDREN AND THOSE WITH SMALL BILE LEAKS. SPHINCTEROTOMY WAS DONE USING AN ERBE GENERATOR (ERBE USA, MOULTON, GA, USA) USING THE ENDOCUT FEATURE. ALL COMPLICATIONS WERE ASSESSED PROSPECTIVELY WITH FOLLOW UP AT 24¿48 H AND 1 MONTH BY AN EXPERIENCED NURSE TO CHECK FOR COMPLICATIONS THAT WERE RECORDED USING CONSENSUS CRITERIA. MODERATE PANCREATITIS (8): CHOLANGITIS (3).

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399264 UNKNOWN FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention