BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY 6F GUIDING CATHETERS

    MDR report key: 2993482 · Received March 7, 2013

    Report

    Report Number
    9616099-2013-00132
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AFTER USED IN PATIENT, THE 6FRENCH STRAIGHT ENVOY CATHETER (670260900/LOT UNK) HAD A HOLE IN YELLOW PART. THE BLIND UNIT REFERS TO A UNIT SENT DIRECTLY FROM THE CUSTOMER. THE UNIT WAS NEW, AND THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. NO DAMAGE WAS NOTICED ON THE INNER OR OUTER PACKAGE. NO ADDITIONAL TORQUE OR MANIPULATION WAS USED AT ANY TIME THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE. THERE WAS NO ADVERSE EVENT REPORTED AND THE DEVICE WILL BE RETURN FOR ANALYSIS. NO FURTHER INFORMATION WAS AVAILABLE. ONE NON STERILE UNIT OF 6F .070 STR ENVOY 90CM WAS RECEIVED FOR ANALYSIS COILED INSIDE OF A PLASTIC BAG. NO VISUAL DAMAGE WAS OBSERVED AT NAKED EYE. A LAB SAMPLE SYRINGE WITH WATER WAS ATTACHED TO CATHETER HUB AND IT WAS FLUSHED A LEAKAGE WAS NOTED ON THE HUB. THE UNIT WAS OBSERVED UNDER MICROSCOPE AND VISION SYSTEM; THERE WAS NO PUNCTURE, HOLE OR SCRATCH NEITHER ON THE BODY/SHAFT NOR AT THE TIP AREA. AFTER IDENTIFY THE LEAKAGE IN THE CATHETER HUB, THE UNIT WAS SENT TO SEM ANALYSIS IN ORDER TO IDENTIFY THE CAUSE OF THE CRACKED CONDITION. SEM RESULTS SHOWED THAT THE CRACK IN THE HUB LEADED THE LEAKAGE EVENT. THE EXTERNAL SURFACE OF THE HUB MATERIAL DID NOT SHOW EVIDENCE OF ANY KIND OF DAMAGE ON THE SURROUNDINGS OF THE CRACK NOR IN THE HUB THREAD. THE INTERNAL SURFACE FOR THE HUB MATERIAL PRESENTED EVIDENCE OF ABRASION MARKS. AS PER THE OBSERVED CONDITIONS, IT IS VERY LIKELY THAT THE CRACKING CONDITION HAS BEEN CAUSED BY THE INTERIOR OF THE HUB MATERIAL. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED; HOWEVER, A TGA ANALYSIS IS RECOMMENDED TO DISREGARD OR CONFIRM A DEGRADATION ISSUE. THE EXACT CAUSE OF THIS CRACKING COULD NOT BE CONCLUSIVELY DETERMINED. CALORIMETRIC TEST WERE CARRIED OUT ON TWO DIFFERENT HUB IN ORDER TO EVALUATE DIFFERENCES BETWEEN THE COMPLAINT AND GOOD SAMPLE THAT COULD PROVIDE INFORMATION TO ELUCIDATE THE POSSIBLE CAUSE OF THE FRACTURED CONDITION OBSERVED DSC ANALYSIS SHOWED THAT GLASS TRANSITION TEMPERATURE DURING (TG) OF CONTROL SAMPLE REMAIN UNAFFECTED DURING BOTH HEATING PROCESSES, WHILE COMPLAINT HUB EXHIBITED A SIGNIFICANT DECREASE IN THE GLASS TRANSITION TEMPERATURE DURING THE SECOND HEATING WHEN COMPARED AGAINST THE FIRST HEATING. THIS CONDITION DEMONSTRATED THE MATERIAL REQUIRED MORE ENERGY (HEAT) TO REACH ITS RUBBERY STATE SUGGESTING A HIGH LEVEL OF INTERTWINED AND STRESS WITHIN THE MOLECULE. BASED ON THE FACT THAT THIS CONDITION DISAPPEARED DURING THE SECOND HEATING PROCESS IT COULD BE PROPOSED THAT STRESS SHOWED BY THE MOLECULE WAS CAUSED BY AN EXTERNAL SOURCE SUCH AS MANUFACTURING PROCESS, STORAGE CONDITION AND TEMPERATURE, USAGE, AMONG OTHERS. TGA RESULTS DEMONSTRATE THE PRESENCE OF HIGHER VOLATILE CONTENT WITHIN SAMPLE FROM THE COMPLAINT HUB, SINCE A PERCENT OF 0.14% WAS OBTAINED IN COMPARISON WITH 0.01 OBTAINED FOR CONTROL SAMPLE. THIS VOLATILE CONTENT IS GENERALLY RELATED TO THE PRESENCE OF INTRAMOLECULAR WATER WITHIN THE POLYMER MOLECULE. THE PRESENCE OF INTRAMOLECULAR MOISTURE WITHIN HOST MOLECULES HAS DEMONSTRATE THE LOSS OF STRENGTH AND INCREASE OF BRITTLENESS, BOTH VARIABLES COULD INDUCE IN HAVE A CRACKED CONDITION, HOWEVER AT THIS POINT IT CANNOT BE DETERMINATE THE SOURCE OF THIS HIGHER CONTENT OF VOLATILES. FINALLY IT WAS DEMONSTRATED THAT COMPLAINT HUB SHOWED A LESS THERMAL STABILITY WHEN COMPARE AGAINST THE CONTROL, THIS CONDITION SUGGEST A POSSIBLE DIFFERENCES IN THE AVERAGE MOLECULAR WEIGHT OF THE POLYMER. THE DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE ACCOUNT. THE REPORTED FAILURE BY THE CUSTOMER AS CRACKED LUER HUB WAS CONFIRMED DURING ANALYSIS; HOWEVER THE ROOT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, CONTROLS ARE PLACED IN THE PRODUCTION LINES TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, ACTION WAS OPENED TO PERFORM THE INVESTIGATION OF THIS FAILURE AND CARRY OUT THE PREVENTIVE/CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    AFTER USED IN PATIENT, THE 6FRENCH STRAIGHT ENVOY CATHETER ((B)(4)/LOT UNK) HAD A HOLE IN YELLOW PART. THE BLIND UNIT REFERS TO A UNIT SENT DIRECTLY FROM THE CUSTOMER. THE UNIT WAS NEW, AND THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. NO DAMAGE WAS NOTICED ON THE INNER OR OUTER PACKAGE. NO ADDITIONAL TORQUE OR MANIPULATION WAS USED AT ANY TIME THAT MAY HAVE CONTRIBUTED TO THE EVENT. OTHER THAN WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE. THERE WAS NO ADVERSE EVENT REPORTED AND THE DEVICE WILL BE RETURN FOR ANALYSIS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98041 ENVOY 6F GUIDING CATHETERS CES GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1