BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DGW .035 FC J3MM 150CM TEF HEP

    MDR report key: 6820630 · Received August 25, 2017

    Report

    Report Number
    1016427-2017-00561
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 7, 2017
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED BUT THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE WIRE CAME OUTSIDE OF THE COATING WHEN A DGW .035 FC J3MM 150CM TEF HEP WIRE WAS ADVANCED BUT WHILE THE COATING PULLED AWAY FROM THE WIRE IT DID NOT SEPARATE. THE PROCEDURE BEING PERFORMED WAS A HEART CATH. THE WIRE POKED THROUGH THE SIDING IN THE AORTA TO THE TARGET LESION (THAT IS WHEN THE COATING PULLED AWAY FROM THE WIRE). THEY DREW BACK THE WIRE TO REMOVE IT. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY AND THE TARGET LESION IS UNKNOWN. ONE NON STERILE UNIT OF DGW .035 FC J3MM 150CM TEF HEP WAS RECEIVED FOR ANALYSIS. PER VISUAL ANALYSIS, THE CORE WIRE WAS FOUND SEPARATED/SEPARATED AT THE GUIDE WIRE DISTAL SECTION AND THE COILED WIRE WAS FOUND UNRAVELED FORM THE CORE WIRE AT THE DISTAL END OF RECEIVED UNIT. NO OTHER ANOMALIES WERE FOUND. THE UNIT WAS SENT TO SEM ANALYSIS IN ORDER TO FIND THE POTENTIAL CAUSE OF THE CORE WIRE SEPARATION AND RESULTS SHOWED THAT THE SAMPLE PRESENTED EVIDENCE OF DUCTILE DIMPLES AT THE SEPARATED AREAS. THE OBSERVED REDUCTION ON THE DIAMETER OF THE WIRE AND THE DUCTILE DIMPLES, SUGGESTS THAT A TENSILE OVERLOAD EVENT OCCURRED PRIOR TO THE SEPARATION OF THE CORE WIRE. NO OTHER ANOMALIES FOUND DURING SEM ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿COATING-WIRES - DELAMINATED - IN PATIENT¿ WAS CONFIRMED SINCE THE COILED WIRE WAS FOUND UNRAVELED FROM THE CORE WIRE AT THE DISTAL END OF RECEIVED UNIT AND THE CORE WIRE WAS RECEIVED FRACTURED. THE EXACT CAUSE OF ISSUE NOTED COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL AND HANDLING FACTORS LIKELY CONTRIBUTED TO THE CORE WIRE FRACTURING AND COILED WIRE UNRAVEL AS EVIDENCED BY THE DUCTILE DIMPLES NOTED DURING SEM ANALYSIS, SUGGESTING TENSILE OVERLOAD. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, USERS ARE WARNED THAT GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. USERS ARE WARNED TO NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. THE PRODUCT ANALYSIS DID NOT PRESENT ANY OBVIOUS INDICATION THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS OR DESIGN OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE WIRE CAME OUT SIDE OF THE COATING WHEN A DGW .035 FC J3MM 150CM TEF HEP WIRE WAS ADVANCED BUT WHILE THE COATING PULLED AWAY FROM THE WIRE IT DID NOT SEPARATE. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS A HEART CATH. THE WIRE POKED THROUGH THE SIDING IN THE AORTA TO THE TARGET LESION (THAT IS WHEN THE COATING PULLED AWAY FROM THE WIRE). THEY DREW BACK THE WIRE TO REMOVE IT. THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY AND THE TARGET LESION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602227 EMERALD DGW .035 FC J3MM 150CM TEF HEP STEERABLE GUIDEWIRE DQX CORDIS CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1