BEUDAMED
    FDA Adverse Event Death Summary report: N

    DGW .035 FC J3MM 150CM TEF

    MDR report key: 10431378 · Received August 20, 2020

    Report

    Report Number
    1016427-2020-04292
    Event Type
    Death
    Date Received
    August 20, 2020
    Date of Event
    July 21, 2020
    Report Date
    September 18, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON CLOSURE WITH A NON-CORDIS DEVICE, A .035" EMERALD DIAGNOSTIC GUIDEWIRE (DGW) WAS CAUGHT IN THE CLOSURE DEVICE, WAS THEN "YANKED" OUT AND UNRAVELED. THE WIRE WAS INTACT WHEN REMOVED FROM THE PATIENT. IT WAS REPLACED WITH ANOTHER WIRE TO COMPLETE THE PROCEDURE. A FEMORAL ARTERY DISSECTION SUBSEQUENTLY OCCURRED AND THERE WAS BLEEDING. THE PATIENT WAS TAKEN TO SURGERY AND SUBSEQUENTLY EXPIRED. THE DEVICE WAS OPENED IN STERILE FIELD. AN ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED PRIOR TO CLOSURE WITH THE NON-CORDIS CLOSURE DEVICE. THE ACCESS SITE WAS THE FEMORAL. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. IT WAS NOT RE-SHAPED BY THE USER. IT WAS NOT USED FOR TREATMENT OF ANOTHER LESION AND WAS IN SITU LESS THAN ONE MINUTE BEFORE THE REPORTED EVENT. THERE WAS DIFFICULTY REMOVING THE WIRE FROM THE CLOSURE DEVICE AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE IT. THEY ARE UNSURE WHAT CAUSED THE DISSECTION AND DID NOT HAVE TROUBLE GETTING ACCESS. ADDITIONAL PROCEDURAL DETAILS AND FILMS WERE REQUESTED BUT NOT PROVIDED. A NON-STERILE EMERALD GUIDEWIRE (DGW .035 FC J3MM 150CM TEF) ALONG WITH A NON-CORDIS CLOSURE DEVICE WAS RECEIVED FOR ANALYSIS. PER VISUAL ANALYSIS, THE COIL WIRE COMPONENT OF THE GUIDEWIRE WAS RECEIVED UNRAVELED/STRETCHED, WHILE THE CORE WIRE OF THE GUIDEWIRE WAS OBSERVED FRACTURE/SEPARATED NEAR THE DISTAL TIP. NO OTHER ANOMALIES WERE FOUND. PER MICROSCOPIC ANALYSIS, THE FRACTURED/SEPARATED CORE WIRE WAS SENT TO SEM ANALYSIS TO DETERMINE THE ROOT CAUSE OF THE FRACTURED / SEPARATED CONDITION. RESULTS SHOWED THAT THE AFFECTED AREAS ON THE CORE WIRE PRESENTED EVIDENCE OF PLASTIC DEFORMATIONS, DUCTILE DIMPLES, AND DIAMETER REDUCTION AT THE POINT OF THE FRACTURE / SEPARATION CONDITION. THE EVIDENCE OF DUCTILE DIMPLES SUGGESTS THAT A TENSILE OVERLOAD EVENT OCCURRED PRIOR TO THE SEPARATION OF THE CORE WIRE. ADDITIONALLY, THE DIAMETER REDUCTION AND PLASTIC DEFORMATIONS FOUND ON THE SEPARATED AREA SUGGESTS A DEVICE MANIPULATION THAT LED TO THE MATERIAL TO SEPARATION. NO OTHER ANOMALIES WERE FOUND DURING SEM ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT: 35260973 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT BY THE CUSTOMER AS ¿GUIDEWIRE-RESISTANCE/FRICTION IN PATIENT¿ COULD NOT BE EVALUATED DUE TO THE NATURE OF THE COMPLAINT. HOWEVER, THE REPORTED EVENT BY THE CUSTOMER AS ¿GUIDEWIRE UNRAVELED / STRETCHED IN PATIENT¿ WAS CONFIRMED DUE TO THE UNRAVELED / STRETCHED CONDITION OF THE GUIDEWIRE AS RECEIVED. ADDITIONALLY, THE GUIDEWIRE WAS RECEIVED WITH A FRACTURED / SEPARATED CONDITION. THE CAUSE OF THE STRETCHED / UNRAVELED AND FRACTURED / SEPARATED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. HOWEVER, THERE IS EVIDENCE THAT THE DEVICE WAS EXPOSED TO A TENSILE FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATED AND UNRAVELED CONDITIONS. WITHOUT PROCEDURAL FILMS OR IMAGING, ¿FEMORAL ARTERY DISSECTION¿ AND ¿DEATH¿ CANNOT BE CONFIRMED, AND THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF A PERCUTANEOUS INTERVENTION AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THIS TYPE OF PROCEDURE CAN DISRUPT THE VESSEL PLAQUE AND INTIMA. VESSEL CHARACTERISTICS SUCH AS CALCIFIED LESIONS OR TORTUOUS VESSELS AND/OR PROCEDURAL FACTORS CAN CONTRIBUTE TO A DISSECTION OCCURRING. DEATH IS A KNOWN POTENTIAL MAJOR ADVERSE CARDIAC EVENT ASSOCIATED WITH A TAVR. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN ACTUAL TYPE OF DEATH, WHETHER IT WAS PUMP FAILURE, OBSTRUCTIVE, OR SUDDEN DEATH DUE TO A CARDIAC ARRHYTHMIA. IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE EMERALD GUIDEWIRE AND THE REPORTED CARDIAC DEATH. ACCORDING TO THE IFU, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿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. MOVEMENT OF TORQUE DEVICE OR METAL INSERTION TOOL ON A GUIDEWIRE'S COATING MAY COMPROMISE THE INTEGRITY OF THE COATING.¿ ¿POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INFECTION, PERFORATION OF THE HEART, INTIMAL VESSEL WALL DAMAGE, DISSECTION, AND PERFORATION.¿ NEITHER THE PHR REVIEW, THE PRODUCT ANALYSIS, NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO ACTIONS WILL BE TAKEN AT THIS TIME.

    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.

    Description of Event or Problem · 1

    UPON CLOSURE WITH A NON-CORDIS DEVICE, A .035" 150CM FIXED-CORE PTFE-COATED 3MM J-CURVED EMERALD DIAGNOSTIC GUIDEWIRE (DGW) WAS CAUGHT IN THE CLOSURE DEVICE, WAS THEN "YANKED" OUT AND UNRAVELED. THE WIRE WAS INTACT WHEN REMOVED FROM THE PATIENT. IT WAS REPLACED WITH ANOTHER WIRE TO COMPLETE THE PROCEDURE. A FEMORAL ARTERY DISSECTION SUBSEQUENTLY OCCURRED AND THERE WAS BLEEDING. THE PATIENT WAS TAKEN TO SURGERY AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN¿S DICTATED SUMMARY AND PROCEDURE LOG AVAILABLE AS WELL AS FILMS ARE AVAILABLE AND HAVE BEEN REQUESTED. THE DEVICE WAS OPENED IN STERILE FIELD. AN ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS PERFORMED PRIOR TO CLOSURE WITH THE NON-CORDIS CLOSURE DEVICE. THE ACCESS SITE WAS THE FEMORAL. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. IT WAS NOT RE-SHAPED BY THE USER. IT WAS NOT USED FOR TREATMENT OF ANOTHER LESION AND WAS IN SITU LESS THAN ONE MINUTE BEFORE THE REPORTED EVENT. THERE WAS DIFFICULTY REMOVING THE WIRE FROM THE CLOSURE DEVICE WAS EXCESSIVE FORCE WAS REQUIRED TO REMOVE IT. THEY ARE UNSURE WHAT CAUSED THE DISSECTION AND DID NOT HAVE TROUBLE GETTING ACCESS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897156 DGW .035 FC J3MM 150CM TEF WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION N/A 35260973

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R PERCLOSE DEVICE| PERCLOSE DEVICE