BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 MC J3MM 150CM TEF AMP

    MDR report key: 6995973 · Received November 2, 2017

    Report

    Report Number
    1016427-2017-00715
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 8, 2017
    Report Date
    November 14, 2017
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS REPORTED THAT WHEN AN EMERALD DIAGNOSTIC GUIDEWIRE (DGW .035 MC J3MM 150CM TEF AMP) WAS REMOVED FROM THE PATIENT, IT WAS FRAYED AND BENT. THE CATHETER WAS NOT REPORTED BEING BENT OR MEETING RESISTANCE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WAS NO REPORT OF APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. APPROACH WAS MADE FROM THE FEMORAL ARTERY. A 6F GUARDIAN WAS WITH GLIDE CATHETER AND WIRE WAS EXCHANGED FOR PCI. THERE WAS ¿NOTHING UNUSUAL¿ OF THE DEVICE PASSING THROUGH ANY ACUTE BENDS. NO ADDITIONAL INFORMATION WAS PROVIDED. A NON-STERILE DGW .035 MC J3MM 150CM TEF AMP EMERALD GUIDEWIRE WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE CORE WIRE WAS OBSERVED PROTRUDED AND TRAPPED BY THE COILED WIRE AT THE POINT WHERE A KINK WAS PRESENT IN THE UNIT (GUIDEWIRE-KINKED DAMAGE AT ¿J¿ SHAPE DISTAL TIP). IT SEEMS AS IF THE GUIDE WIRE WAS STRETCHED/ FORCIBLY PULLED AT DISTAL TIP AND CORE WIRE WAS DISLODGED AND TRAPPED BY THE COILED WIRE ONCE THE GUIDE WIRE RESUMED ITS POSITION. NO OTHER ISSUES WERE FOUND. SEE PICTURES. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿DISTAL TIP FRAYED/SPLIT/TORN¿ WAS NOT CONFIRMED SINCE NO FRAYED/SPLIT/TORN CONDITION WAS OBSERVED DURING ANALYSIS OF THE RETURNED DEVICE. HOWEVER, THE CORE WIRE WAS OBSERVED PROTRUDED AND TRAPPED BY THE COILED WIRE. THE REPORTED ¿GUIDEWIRE KINKED/BENT¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE CAUSE OF THE GUIDEWIRE KINKED/BENT AND PROTRUDING CORE WIRE CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL AND HANDLING FACTORS MOST LIKELY CONTRIBUTED TO THE ISSUE REPORTED AS EVIDENCED BY THE STRETCHED AND FORCIBLY PULLED DISTAL TIP, AND THE CORE WIRE WAS DISLODGED AND TRAPPED BY THE COILED WIRE AT THE POINT OF A KINK. THE INSTRUCTIONS FOR USE CAUTIONS USERS TO INSPECT FOR KINKS AND BENDS, OR OTHER SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. CATHETER KINKING DURING CLINICAL USE IS A KNOWN AND COMMON OCCURRENCE AND IS TYPICALLY RELATED TO ANATOMY, TECHNIQUE, PHYSICIAN SKILL, AND VESSEL TORTUOSITY. AS WARNED IN THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR SIGNS OF DAMAGE. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR.¿ NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS REPORTED THAT WHEN AN EMERALD DIAGNOSTIC GUIDEWIRE (DGW .035 MC J3MM 150CM TEF AMP) WAS REMOVED FROM THE PATIENT, IT WAS FRAYED AND BENT. THE CATHETER WAS NOT REPORTED BEING BENT OR MEETING RESISTANCE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WAS NO REPORT OF APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. APPROACH WAS MADE FORM THE FEMORAL ARTERY. A 6F GUARDIAN WAS WITH GLIDE CATHETER AND WIRE WAS EXCHANGED FOR PCI. THERE WAS ¿NOTHING UNUSUAL¿ OF THE DEVICE PASSING THROUGH ANY ACUTE BENDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777407 DGW .035 MC J3MM 150CM TEF AMP WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 502571A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1