BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS ONE ACTION STENT INTRODUCTION SYSTEM

    MDR report key: 7943033 · Received October 8, 2018

    Report

    Report Number
    3001845648-2018-00473
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    September 8, 2018
    Report Date
    October 8, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    00827002256583
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: AS THE PRODUCT WAS NOT RETURNED A DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. LAB EVALUATION: THE OACL-7-9 DEVICE OF LOT NUMBER C1483074 WHICH IS INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE OACL-7-9 DEVICE OF LOT NUMBER C1483074 INVOLVED IN THIS COMPLAINT DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE TO SUGGEST THIS ISSUE EFFECTS THE ENTIRE LOT C1483074, UPON REVIEW OF THE COMPLAINTS HISTORY, THIS FAILURE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT C1483074. PRIOR TO DISTRIBUTION, ALL OACL-7-9 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY . THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IFU REVIEW: IT SHOULD BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE (IFU0096-0) STEP 3 THE USER IS INSTRUCTED ¿WITH THE ELEVATOR OPEN, ADVANCE DEVICE IN SHORT INCREMENTS UNTIL ENDOSCOPICALLY VISUALISED EXITING SCOPE. NOTE: AS FRONT FLAP OF STENT ENTERS ACCESSORY CHANNEL, KEEP POSITIONING SLEEVE OVER BACK FLAP UNTIL COMPLETELY IN ACCESSORY CHANNEL. SLIDE POSITIONING SLEEVE OVER PUSHING CATHETER, KEEPING IT CLEAR OF ACCESSORY CHANNEL¿ AS PER THE INSTRUCTIONS FOR USE (IFU0096-0) THE USER IS INSTRUCTED TO ¿MAINTAIN THE POSITION OF THE GUIDING CATHETER AND ADVANCED THE STENT INTO THE DESIRED POSITION USING THE PUSHING CATHETER¿. ROOT CAUSE: IT SHOULD BE NOTED THAT THE CUSTOMER STATED THAT ¿HE WAS HAVING DIFFICULTY PUSHING THE STENT. HE THOUGHT IT MAY HAVE BEEN CAUGHT ON THE ELEVATOR OF THE ENDOSCOPE, BUT HE ALSO DID NOT THINK HIS TECH WAS GIVING HIM APPROPRIATE TENSION ON THE OASIS INTRODUCER.¿ A POSSIBLE ROOT CAUSE OF PATIENT ANATOMY MAY POTENTIALLY BE ASSIGNED TO THIS COMPLAINT AS PER THE EVIDENCE RECEIVED IN THE CUSTOMER ADDITIONAL INFORMATION WHERE THE CUSTOMER STATED THAT THERE WAS RESISTANCE FELT WHEN ADVANCING THE STENT THROUGH THE OBSTRUCTED AREA, HOWEVER IT SHOULD BE NOTED THAT THE CUSTOMER STATED THAT ¿HE WAS HAVING DIFFICULTY PUSHING THE STENT. HE THOUGHT IT MAY HAVE BEEN CAUGHT ON THE ELEVATOR OF THE ENDOSCOPE, BUT HE ALSO DID NOT THINK HIS TECH WAS GIVING HIM APPROPRIATE TENSION ON THE OASIS INTRODUCER¿ THEREFORE IT IS ALSO PROBABLY THAT THE STENT MAY HAVE GOTTEN CAUGHT ON THE ELEVATOR OR THAT THERE WASN¿T ENOUGH TENSION ON THE INTRODUCER WHILE ATTEMPTING TO ADVANCE THE STENT, AS PER THE INSTRUCTIONS FOR USE (IFU0096-0) THE USER IS INSTRUCTED TO ¿MAINTAIN THE POSITION OF THE GUIDING CATHETER AND ADVANCED THE STENT INTO THE DESIRED POSITION USING THE PUSHING CATHETER¿, HOWEVER AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND AS THE OPERATIONAL CONDITIONS OF USE CANNOT BE REPLICATED IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THE CUSTOMER COMPLAINT. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE NO RISK (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". AS REPORTED TO CUSTOMER RELATIONS, "THE BACK FLANGE WAS TORN OFF SO THEY HAD TO DEPLOY ANOTHER STENT. THEY COMPLETED THE CASE SUCCESSFULLY."

    Description of Event or Problem · 0

    THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" AS REPORTED TO CUSTOMER RELATIONS, "THE BACK FLANGE WAS TORN OFF SO THEY HAD TO DEPLOY ANOTHER STENT. THEY COMPLETED THE CASE SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784701 OASIS ONE ACTION STENT INTRODUCTION SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G25658 C1483074 00827002256583

    Patients

    Seq Age Sex Outcome Treatment
    1