BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY 6F GUIDING CATHETERS

    MDR report key: 6608849 · Received June 2, 2017

    Report

    Report Number
    3008264254-2017-00065
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 8, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K093184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER UPDATED. FOLLOW UP 1 LISTED INCORRECT PERSON. THE REPORTER IS A COMPANY EMPLOYEE REPORTING ON BEHALF OF THE FACILITY.

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 3008264254-2017-00065. LOT# 17552880 PROVIDED BY REPORTED HOWEVER LOT IS INVALID. UDI UNAVAILABLE; LOT UNKNOWN. MANUFACTURING DATE UNAVAILABLE , LOT UNKNOWN. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS FINAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 3008264254-2017-00065. LOT# , EXPIRATION DATE AND UDI UPDATED. (B)(4). MANUFACTURING DATE UPDATED. A NON-STERILE ENVOY 6F, MPC 90CM WAS RECEIVED INSIDE AN UNKNOWN POUCH INSIDE OF A PLASTIC BAG. NO DAMAGES WERE NOTED ON THE HUB OF THE ENVOY. THE ENVOY BODY WAS INSPECTED AND IT WAS FOUND KINKED AT 69.5 CM FROM THE PROXIMAL END OF THE HUB. COMPRESSED SECTION WAS FOUND AT 0.3 MM FROM THE DISTAL END TIP. THE ID AND OD OF THE ENVOY WAS MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. ACTUAL ID: 0. 070¿, SPECIFICATION: 0.070 ±.0005"; ACTUAL BODY OD: 0.0831¿, SPECIFICATION: .082 ±.0015¿, MAXIMUM OD FOR THE FUSE JOINTS IS .0853¿, ACTUAL BRITE TIP OD (.02MM FROM THE DISTAL END) .0852¿, ACTUAL FUSE JOINT 24 OD (91 CM FROM THE PROXIMAL END OF HUB) .0834¿, ACTUAL FUSE JOINT 16 OD (86.5 CM FROM THE PROXIMAL END OF HUB) .0830¿, ACTUAL FUSE JOINT 17 OD (75.5 CM FROM THE PROXIMAL END OF HUB) .0832¿. THE FUNCTIONAL ANALYSIS WAS PERFORMED. THE RECEIVED DEVICE WAS FLUSHED OUT USING A LAB SAMPLE SYRINGE (NIPRO) THE WATER CAME OUT FROM THE DISTAL END OF THE DEVICE. A 0.038¿ GUIDE WIRE CORDIS LAB SAMPLE WAS INTRODUCED INTO THE ENVOY AND IT ADVANCED SMOOTHLY UNTIL THE DISTAL TIP AND RESISTANCE WAS EXPERIENCED WHEN THE GUIDEWIRE PASSED THROUGH KINKED AND COMPRESSED SECTION FOUND ON THE BODY. THE ENVOY WAS INTRODUCED INTO THE CANNULA CORDIS LAB SAMPLE AND IT ADVANCED UNTIL THE CANNULA DISTAL TIP END AND RESISTANCE WAS FELT IN BRITE TIP FUSE AREA. HOWEVER; IT PASSED TOTALLY THROUGH THE BRITE TIP FUSE AREA OF THE CANNULA LAB SAMPLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 17652880 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER AS ¿BRITE TIP/DISTAL TIP ¿ CRACKED-IN PATIENT¿ WAS NOT CONFIRMED. THE FAILURE REPORTED AS ¿CATHETER (BODY/SHAFT)- IMPEDED¿ WAS NOT CONFIRMED. THE DAMAGES FOUND ON THE RECEIVED DEVICE WERE APPARENTLY CAUSED BY EXCESSIVE FORCE APPLIED ON IT BUT IT COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS, PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THIS DAMAGE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE THE ENVOY CATHETER (67025690/17552880) WOULD NOT ADVANCE UP THE CORDIS SHEATH. WHEN IT DID ADVANCE IT WAS STIFF AND CAUSED THE ENVOY TO CRACK AT THE TIP. THE PROCEDURE WAS COMPLETED USING A SAME LIKE PRODUCT. THE PROCEDURE WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. THERE WERE NO DAMAGES NOTED ON THE ENVOY CATHETER AND NO DAMAGES WERE NOTED ON THE CORDIS SHEATH PRIOR TO USE OR UPON REMOVAL. THERE WERE NO ADVERSE EVENTS. THE COMPLAINT DEVICE ALONG WITH THE SHEATH ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388430 ENVOY 6F GUIDING CATHETERS PERCUTANEOUS CATHETER DQY CODMAN AND SHURTLEFF, INC NA 17652880

    Patients

    Seq Age Sex Outcome Treatment
    1