BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 2329403 · Received November 9, 2011

    Report

    Report Number
    1016427-2011-00114
    Event Type
    Death
    Date Received
    November 9, 2011
    Date of Event
    September 22, 2011
    Report Date
    October 11, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CC UPDATED WITH FILM REVIEW REPORT. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE 195 CM SGW ATW .014 J FLOPPY GUIDEWIRE FROM THE PATIENT, THE DISTAL TIP WAS NOTED TO BE FRACTURED AND WAS STUCK IN THE PROXIMAL END OF THE UNKNOWN STENT. AN ATTEMPT TO RETRIEVE THE FRACTURED GUIDEWIRE USING A SNARE DEVICE WAS UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IMMEDIATELY AFTER THE EVENT. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED FIBRILLATION AND EXPIRED. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. A CD WITH PROCEDURAL FILMS WAS RECEIVED AND REVIEWED BY AN INDEPENDENT CARDIOLOGIST. THE RESULTS OF THE FILM REVIEW ARE AS FOLLOWS: A DEEP SEATED Q TYPE GUIDE WAS UTILIZED TO ACCESS THE LEFT CORONARY SYSTEM AND DOUBLE-WIRE TECHNIQUE USING APW014J FLOPPY GUIDE-WIRES WERE UTILIZED WITH THE DISTAL TIPS PLACED IN THE LAD AND A SECOND WIRE IN THE DIAGONAL. OF NOTE, ON THE ANGIOGRAM, THE DISTAL TIP OF THE WIRE APPEARS INTERTWINED AND TWISTED TO A SIGNIFICANT DEGREE. AN INTERVENTION TO THE PROXIMAL LAD WAS PERFORMED AND A STENT WAS PLACED JAILING THE DIAGONAL FOLLOWING WHICH DURING REMOVAL OF THE GUIDE-WIRE THE DISTAL TIP AVULSED. IT APPEARED KNOTTED AND WAS STUCK IN THE PROXIMAL END OF THE LEFT MAIN AND THE PROXIMAL LAD STENT. THE ATTEMPTS TO REMOVE THIS WERE UNSUCCESSFUL AND UNFORTUNATELY THE PATIENT DEVELOPED VENTRICULAR ARRHYTHMIAS AND SUCCUMBED TO THIS COMPLICATION. IN REVIEW, THIS WAS A COMPLEX CASE AND FULL DETAILS ARE NOT READILY AVAILABLE, HOWEVER, I DO BELIEVE THAT THE GUIDE-WIRE WAS WRAPPED AROUND ITSELF IN THE DISTAL PORTION OF THE VESSEL AND UPON RETRIEVAL, IT MAY HAVE BEEN SNAGGED IN THE STENT STRUTS AND WAS SEPARATED FROM THE CORE OF THE WIRE. THIS KNOTTED PORTION OF THE GUIDE-WIRE WAS PRESENT IN THE LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING AND MAY HAVE CONTRIBUTED TO ISCHEMIA WHICH LEAD TO THE PATIENT'S VENTRICULAR ARRHYTHMIAS AND UNFORTUNATE DEMISE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE FLEXIBLE, "DELICATE" NATURE OF THE "FLOPPY" TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). IT IS POSSIBLE THAT ADVANCEMENT OF THE WIRE THROUGH A PRE-EXISTING STENT RESULTED IN THE DISTAL REGION OF THE SPECIMEN WIRE BECOMING ENTRAPPED IN THE STENT AND THE VESSEL. THE COMPLAINT DOCUMENTATION DOES NOT INDICATE HOW LONG WAS THE ENTRAPMENT OF THE WIRE NOTED OR HOW THE ENTRAPMENT CONDITION WAS IDENTIFIED. TIP FRACTURES HAVE BEEN REPORTED IN PROCEDURES INVOLVING GUIDEWIRE ENTRAPMENT, TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. THE IFU WARNS TO "NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE." 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. IN ADDITION, "IF ANY RESISTANCE IS FELT, I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT, WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THIS MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. BASED ON THE INFORMATION PROVIDED BY THE INDEPENDENT CARDIOLOGIST, THERE ARE POSSIBLE PROCEDURAL FACTORS (WIRE MAY HAVE SNAGGED IN THE STENT STRUTS AND SEPARATED UPON REMOVAL) THAT MAY HAVE CONTRIBUTED TO THE EVENT RESULTING IN VENTRICULAR FIBRILLATION AND SUBSEQUENT DEATH. WITHOUT THE PRODUCT TO CONDUCT AN ANALYSIS AND WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE 195 CM. SGW ATW .014 J FLOPPY GUIDEWIRE FROM THE PATIENT, THE DISTAL TIP WAS NOTED TO BE FRACTURED AND WAS STUCK IN THE PROXIMAL END OF THE UNKNOWN STENT. AN ATTEMPT TO RETRIEVE THE FRACTURED GUIDEWIRE USING A SNARE DEVICE WAS UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IMMEDIATELY AFTER THE EVENT. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED FIBRILLATION AND EXPIRED. ADDITIONAL INFORMATION AND PROCEDURAL FILMS HAVE BEEN REQUESTED BUT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE FLEXIBLE, "DELICATE" NATURE OF THE "FLOPPY" TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). IT IS POSSIBLE THAT ADVANCEMENT OF THE WIRE THROUGH A PRE-EXISTING STENT RESULTED IN THE DISTAL REGION OF THE SPECIMEN WIRE BECOMING ENTRAPPED IN THE STENT AND THE VESSEL. THE COMPLAINT DOCUMENTATION DOES NOT INDICATE HOW LONG WAS THE ENTRAPMENT OF THE WIRE NOTED OR HOW THE ENTRAPMENT CONDITION WAS IDENTIFIED. TIP FRACTURES HAVE BEEN REPORTED IN PROCEDURES INVOLVING GUIDEWIRE ENTRAPMENT, TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. THE IFU WARNS TO "NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. 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." IN ADDITION, "IF ANY RESISTANCE IS FELT, I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT, WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THIS MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL." BASED ON THE LIMITED PROCEDURAL INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE BROKEN WIRE RESULTING IN VENTRICULAR FIBRILLATION AND SUBSEQUENT DEATH. WITHOUT THE PRODUCT TO CONDUCT AN ANALYSIS AND WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE 195 CM. SGW ATW .014 J FLOPPY GUIDEWIRE FROM THE PATIENT THE DISTAL TIP WAS NOTED TO BE FRACTURED/SEPARATED AND WAS STUCK IN THE PROXIMAL END OF THE UNKNOWN STENT. AN ATTEMPT TO RETRIEVE THE FRACTURED GUIDEWIRE USING A SNARE DEVICE WAS UNSUCCESSFUL. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IMMEDIATELY AFTER THE EVENT. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED FIBRILLATION AND EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R