BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 3213191 · Received July 9, 2013

    Report

    Report Number
    1016427-2013-00091
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WIRE WAS ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT. THE WIRE TIP DID NOT REPEATEDLY PROLAPSED DURING PLACEMENT AND DID NOT REMAIN IN A PROLAPSED POSITION DURING TREATMENT OF THE LESION. THE WIRE TIP WAS ADVANCED INTO THE DISTAL VASCULATURE. THE WIRE WAS USED IN THE SIDE BRANCH AND WAS NOT JAILED AT ANY TIME BEHIND A STENT. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME PRIOR TO THE EVENT AND WAS NOT TORQUED AGAINST RESISTANCE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: 6F AVANTI SHEATH INTRODUCER, .035 WHOLEY WIRE, BOSTON SCIENTIFIC RUNWAY CLS3.5 GUIDE CATHETER, BOSTON SCIENTIFIC EMERGE 2.5X20MM, 2.0X15MM BALLOON, BOSTON SCIENTIFIC PT CHOICE .014 J-TIP WIRE, PROMUS ELEMENT 2.75X16 STENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A LEFT HEART PERCUTANEOUS CORONARY INTERVENTION (PCI), THE TIP OF A 0.014X190CM ATW GUIDEWIRE BECAME DISLODGED INSIDE THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP AND ULTIMATELY STENTED OVER THE BROKEN TIP OF THE WIRE. THE PHYSICIAN STATED THAT THE PATIENT WAS COMFORTABLE AND FREE OF CHEST PAIN AND DISCOMFORT. ACCESS WAS ACHIEVED VIA THE RIGHT FEMORAL ACCESS WITH A 6F CORDIS AVANTI SHEATH INTRODUCER. A .035 NON-CORDIS WIRE WAS ADVANCED AND A NON-CORDIS GUIDE CATHETER WAS ADVANCED OVER THE WIRE AND THE WIRE WAS REMOVED. A 0.014 NON-CORDIS J-TIP WIRE WAS ADVANCED DOWN INTO CIRCUMFLEX ARTERY AND THE .014X190CM ATW WIRE WAS ADVANCED DOWN INTO THE RAMUS ARTERY. A KISSING BALLOON TECHNIQUE WAS PERFORMED AT THE BIFURCATION OF THE CIRCUMFLEX AND RAMUS ARTERIES WITH A NON-CORDIS BALLOON CATHETER AND A NON-CORDIS BALLOON, RESPECTIVELY. A NON-CORDIS STENT WAS DEPLOYED IN THE CIRCUMFLEX ARTERY. WHILE REMOVING THE ATW WIRE, THE TIP BECAME DISLODGED INSIDE THE ARTERY. THE WIRE HAD BEEN ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT, AND THERE WAS RESISTANCE/FRICTION NOTED BETWEEN THE WIRE AND THE STENT UPON WITHDRAWAL. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP AND ULTIMATELY STENTED OVER THE BROKEN TIP OF WIRE AS THE VESSEL WAS SMALL AND THE DISTAL TIP COULD NOT BE SNARED. THE LESION HAD NO EVIDENCE OF TORTUOSITY, BUT WAS CALCIFIED, BIFURCATING, AND HAD 80% STENOSIS. THE PRODUCT WAS NOT RESTERILIZED, AND WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END AND HAD NO KINKS OR VISIBLE DAMAGE PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED BY THE USER AND WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE WIRE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE AND THERE WAS NO DIFFICULTY TRACKING THE WIRE TO OR THROUGH THE LESION. THE WIRE ¿BEHAVED¿ NORMALLY AND DID NOT KINK DURING USE. THE WIRE TIP DID NOT REPEATEDLY PROLAPSED DURING PLACEMENT AND DID NOT REMAIN IN A PROLAPSED POSITION DURING TREATMENT OF THE LESION. THE WIRE TIP WAS ADVANCED INTO THE DISTAL VASCULATURE. THE WIRE WAS USED IN THE SIDE BRANCH AND WAS NOT JAILED AT ANY TIME BEHIND A STENT. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME PRIOR TO THE EVENT AND WAS NOT TORQUED AGAINST RESISTANCE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. A NON-STERILE UNIT OF SGW ATW .014 STR FLOPPY 195CM WAS RECEIVED INSIDE OF A PLASTIC BAG. THE DISTAL TIP SECTION WAS OBSERVED STRETCHED AND ENTANGLED WITH THE BODY OF WIRE. THE DEVICE WAS INSPECTED UNDER SYSTEM VISION AND A STRETCHED CONDITION WAS OBSERVED IN COIL WIRE DISTAL TIP AND THE CORE WIRE WAS OBSERVED FRACTURED. A SEM ANALYSIS SHOWED THAT THE CORE WIRE PRESENTED EVIDENCE OF DUCTILE DIMPLES. IT APPEARS THAT THE SEPARATION OCCURRED WHILE THE WIRE WAS BEING STRETCHED/PULLED DUE TO THE DUCTILE DIMPLES. HOWEVER, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS ¿DISTAL TIP/FRACTURED-SEPARATED¿ WAS CONFIRMED DUE TO THE CONDITION OF DEVICE RECEIVED, ALSO A STRETCHED CONDITION WAS FOUND DURING ANALYSIS. THE EXACT CAUSE OF THESE CONDITIONS COULD NOT BEEN CONCLUSIVELY DETERMINED; HOWEVER, ACCORDING TO THE SEM ANALYSIS RESULTS, PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THESE ISSUES. 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). 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. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HEART PERCUTANEOUS CORONARY INTERVENTION (PCI), THE TIP OF A 0.014X190CM ATW GUIDEWIRE BECAME DISLODGED INSIDE THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP AND ULTIMATELY STENTED OVER THE BROKEN TIP OF THE WIRE. PHYSICIAN STATED PATIENT WAS COMFORTABLE AND FREE OF CHEST PAIN AND DISCOMFORT. ACCESS WAS ACHIEVED VIA RIGHT FEMORAL ACCESS WITH A 6F CORDIS AVANTI SHEATH INTRODUCER. A .035 NON-CORDIS WIRE WAS ADVANCED AND A NON-CORDIS GUIDE CATHETER WAS ADVANCED OVER THE WIRE AND WIRE REMOVED. THE NON-CORDIS CATHETER ENGAGED WITH OSTIUM OF THE LEFT CORONARY ARTERY. A 0.014 NON-CORDIS J-TIP WIRE WAS ADVANCED DOWN INTO CIRCUMFLEX ARTERY AND THE .014X190CM ATW WIRE WAS ADVANCED DOWN INTO THE RAMUS ARTERY. A KISSING BALLOON TECHNIQUE WAS PERFORMED AT THE BIFURCATION OF CIRCUMFLEX AND RAMUS ARTERIES WITH NON-CORDIS BALLOON CATHETER AND NON-CORDIS BALLOON, RESPECTIVELY. A NON-CORDIS STENT WAS DEPLOYED IN THE CIRCUMFLEX ARTERY. WHILE REMOVING THE ATW WIRE, THE TIP BECAME DISLODGED INSIDE THE ARTERY. THERE WAS RESISTANCE/FRICTION NOTED BETWEEN THE WIRE AND THE STENT UPON WITHDRAWAL. PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP AND ULTIMATELY STENTED OVER THE BROKEN TIP OF WIRE AS THE VESSEL WAS SMALL AND WAS UNABLE TO RETRIEVE THE TIP WITH SNARE. THE LESION HAD NO EVIDENCE OF TORTUOSITY, BUT WAS CALCIFIED, BIFURCATING, AND HAD 80% STENOSIS. THE PRODUCT WAS NOT RESTERILIZED, AND WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END AND HAD NO KINKS OR VISIBLE DAMAGE PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED BY THE USER AND WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE WIRE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE AND THERE WAS NO DIFFICULTY TRACKING THE WIRE THROUGH THE LESION. THE WIRE ¿BEHAVED¿ NORMALLY AND DID NOT KINK DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313461 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F1212070

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S