BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 8168619 · Received December 17, 2018

    Report

    Report Number
    3001845648-2018-00593
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 17, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K851962, COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 , INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON , INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. LAB EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE (POSSIBLE): DUE TO LIMITED INFORMATION AND AS THE DEVICES WERE NOT RETURNED FOR EVALUATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT. FROM ENGINEERING ASSESSMENT OF THE INFORMATION AVAILABLE, IT IS POSSIBLE THAT THE INCORRECT STENT SIZE AND TYPE WAS CHOSEN FOR THE PROCEDURE. IT IS ALSO POSSIBLE THAT THE STENT MIGRATED AND CAUSED PERFORATION AS BOTH MIGRATION AND PERFORATION ARE POTENTIAL COMPLICATIONS DOCUMENTED IN THE INSTRUCTIONS FOR USE. FOR RISK PURPOSES, WORST CASE SCENARIO WILL BE CHOSEN AND THEREFORE THE KNOWN COMPLICATIONS OF MIGRATION AND PERFORATION WILL BE USED IN THE DETERMINATION OF RISK. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CLSO-10-12 DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL CLSO DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN CIRL PROCEDURES. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0045-6, "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE 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". PATIENT OUTCOME: THE STENT PENETRATED THROUGH THE DUODENAL WALL, REQUIRING ANOTHER ECRP PROCEDURE TO REMOVE THE STENT AND PLACE THE PIGTAIL STENT. PATIENT WAS IN HOSPITAL FOR 3 TO 4 DAYS & HAD AN ER VISIT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE STENT PENETRATED THROUGH THE DUODENAL WALL, REQUIRING ANOTHER ECRP PROCEDURE TO REMOVE THE STENT AND PLACE THE PIGTAIL STENT. PATIENT WAS IN HOSPITAL FOR 3 TO 4 DAYS & HAD AN ER VISIT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K851962. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA PHONE, "THE STENT WAS PLACED ON AUG 30 OF THIS YEAR, THE PATIENT CAME BACK ON SEPT 20 WITH ABDOMINAL PAIN. THAT'S WHEN THEY FOUND THE TIP OF THE STENT PENETRATED THROUGH THE DUODENAL WALL. EXCHANGED FOR A PIGTAIL STENT. THE CUSTOMER REQUIRED A HOSPITAL STAY FOR 3 OR 4 DAYS."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA PHONE, "THE STENT WAS PLACED ON (B)(6) OF THIS YEAR, THE PATIENT CAME BACK ON (B)(6) WITH ABDOMINAL PAIN. THAT'S WHEN THEY FOUND THE TIP OF THE STENT PENETRATED THROUGH THE DUODENAL WALL. EXCHANGED FOR A PIGTAIL STENT. THE CUSTOMER REQUIRED A HOSPITAL STAY FOR 3 OR 4 DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009814 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R