BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT

    MDR report key: 9641459 · Received January 29, 2020

    Report

    Report Number
    3001845648-2020-00048
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    May 11, 2020
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CORRECTION REPORT TO AMEND TO THE FILE A MALFUNCTION REPORT. CUSTOMER NAME : DR. (B)(6). ADDRESS : (B)(6). E-MAIL: (B)(6). DEVICE EVALUATION: THE BILIARY PLASTIC STENT OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE ¿AHMED AT AL. 2018. ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE: RESULTS OF LONG-TERM FOLLOW-UP¿ TWO TYPES OF STENT WERE USED IN THIS LITERATURE REVIEW: BONA STENT, STANDARD SCI TECH INC., SEOUL, KOREA AND A BILIARY PLASTIC STENT (¿DOUBLE PIGTAIL PLASTIC STENT 7FR, 10 CM, COOK MEDICAL, BLOOMINGTON, INDIANA, USA¿). THE EVENT LOCATION IS POSSIBLE JAPAN OR EGYPT, TWO PR¿S HAVE BEEN CREATED TO CAPTURE EACH LOCATION. PR (B)(4) CAPTURES JAPAN, PR (B)(4) CAPTURES EGYPT. LAB EVALUATION: N/A. IMAGE REVIEW: N/A. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE BILIARY PLASTIC STENT DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL BILIARY PLASTIC STENT DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE BILIARY STENTS DEVICES COULD NOT BE COMPLETE AS THE LOT NUMBERS ARE UNKNOWN. AS PER INSTRUCTIONS FOR USE, IFU0045-7, INTENDED USE SECTION: ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ NOTES SECTION: ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ ALSO WITH THE POTENTIAL COMPLICATIONS IT WARNS THE USER OF "POTENTIAL COMPLICATION: 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. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. PER THE INPUT FROM OUR MEDICAL ADVISOR, THE REPORTED EFFECT OF PNEUMOPERITONEUM THAT WAS SEEN WAS A PROCEDURE RELATED COMPLICATION. NOT RELATED TO DEVICE". SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT SUFFERED PNEUMOPERITONEUM REQUIRING CONSERVATIVE TREATMENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THIS IS A CANCELLATION REPORT. THIS FILE IS NO LONGER REPORTABLE AS THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016). CLINICAL ASSESSMENT RECEIVED CONFIRMED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PNEUMOPERITONEUM. CUSTOMER NAME : DR. (B)(6), ADDRESS : DEPARTMENT OF INTERNAL MEDICINE, (B)(6), (B)(6), JAPAN. E-MAIL: (B)(6).

    Description of Event or Problem · 0

    LITERATURE COMPLAINT: AHMED AT AL. 2018. ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE: RESULTS OF LONG-TERM FOLLOW-UP. IN THIS STUDY, CONSECUTIVE PATIENTS WHO UNDERWENT EUS GBD FOR ACUTE CHOLECYSTITIS BETWEEN FEBRUARY 2014 AND SEPTEMBER 2016. A DOUBLE PIGTAIL PLASTIC STENT (7FR, 10 CM, COOK MEDICAL, BLOOMINGTON, INDIANA, USA) WAS PLACED WITHIN THE METALLIC STENT TO PREVENT STENT MIGRATION. PNEUMOPERITONEUM WAS SEEN IN ONE PATIENT AND RESPONDED WELL TO CONSERVATIVE TREATMENT.

    Description of Event or Problem · 0

    THIS IS A CANCELLATION REPORT. THIS FILE IS NO LONGER REPORTABLE AS THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016). CLINICAL ASSESSMENT RECEIVED CONFIRMED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PNEUMOPERITONEUM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITERATURE COMPLAINT: AHMED AT AL. 2018. ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE: RESULTS OF LONG-TERM FOLLOW-UP. IN THIS STUDY, CONSECUTIVE PATIENTS WHO UNDERWENT EUS GBD FOR ACUTE CHOLECYSTITIS BETWEEN FEBRUARY 2014 AND SEPTEMBER 2016. A DOUBLE PIGTAIL PLASTIC STENT (7FR, 10 CM, COOK MEDICAL, BLOOMINGTON, INDIANA, USA) WAS PLACED WITHIN THE METALLIC STENT TO PREVENT STENT MIGRATION. PNEUMOPERITONEUM WAS SEEN IN ONE PATIENT AND RESPONDED WELL TO CONSERVATIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105085 BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention