BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW GUIDEWIRE

    MDR report key: 2994304 · Received March 8, 2013

    Report

    Report Number
    1016427-2013-00027
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING THE PROCEDURE, WHILE TRYING TO PULL THE SGW ATW .014 STR FLOPPY 195CM GUIDEWIRE WIRE OUT OF THE PATIENT, THE OPERATOR FELT THAT THE WIRE WAS STUCK IN THE VASCULATURE DISTAL TO THE LESION. THEY NEEDED TO ACTIVATE A GREAT DEAL OF FORCE IN ORDER TO GET THE WIRE TO MOVE. THE WIRE THAN SPLIT, AND UNDER SCREENING, IT WAS SHOWN THAT THE MAIN PART OF THE WIRE STAYED IN THE LEFT ANTERIOR DESCENDING (LAD) AND THE PART THAT SPLIT ENTERED THE DIAGONAL BRANCH. THE HEALTH CARE PROFESSIONAL (HCP) USED ANOTHER WIRE TO REMOVE THE ATW GUIDEWIRE. THE PROCEDURE WAS PROLONGED APPROXIMATELY THIRTY (30) MINUTES DUE TO THE REPORTED EVENT. THE TARGET LESION WAS THE MID LAD AND WAS REPORTED TO BE A 100% STENOSIS-STEMI AND WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE EVENT OCCURRED POST-BALLOONING PRIOR TO STENTING. THE PRODUCT WAS NOT RE-STERILIZED. THE GUIDEWIRE WAS NOT REMOVED FROM THE DISPENSER BY THE FLOPPY END AND WAS NOT NOTED TO BE KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE GUIDEWIRE WAS RE-SHAPED BY THE PHYSICIAN WITH A NEEDLE. THERE WAS NO REPORTED DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVED NORMALLY WITH GOOD TORQUE RESPONSE. THE DISTAL TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO REPORTED RESISTANCE/FRICTION DURING INSERTION, BUT THERE WAS DURING WITHDRAWAL INTO THE GUIDING CATHETER. THE WIRE REMAINED IN A PROLAPSED POSITION DURING TREATMENT OF THE LESION. THE WIRE WAS POSITIONED IN THE DISTAL VASCULATURE, BUT DID NOT REPEATEDLY PROLAPSE DURING PLACEMENT. THE WIRE DID NOT BECOME FIXED OR CAUGHT IN THE LESION, BUT DID IN THE DISTAL VESSEL. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE AND WAS REMOVED INTACT FROM THE PATIENT. THE PATIENT'S CURRENT STATUS IS GOOD. ONE NON-STERILE GUIDEWIRE SGW ATW .014 STR FLOPPY 195CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DISTAL TIP WAS FOUND UNRAVELED, AND THE COIL WIRE WAS FRACTURED/ SEPARATED FROM THE CORE WIRE. NO OTHER ANOMALIES WERE OBSERVED. SEM ANALYSIS WAS PERFORMED FOR THE SGW ATW GUIDE WIRE DEVICE TO DETERMINE THE CAUSE OF THE FRACTURE; RESULTS SHOWED THAT THE CORE WIRE PRESENTED EVIDENCE OF SMEARING AND REVERSE BENDING. IT APPEARS THAT THE SEPARATION OCCURRED WHILE THE SAMPLE PIECE WAS BEING BENDING DUE TO THE SMEARING AND REVERSE BENDING. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE. SINCE NO PRODUCT LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORDS COULD BE REVIEW. PROCEDURE FILMS WERE REVIEWED BY A CARDIOLOGY CONSULTANT WHO CONCLUDED THE FOLLOWING: 'IT DOES APPEAR THAT THE WIRE WAS POSITIONED IN THE DISTAL MICROVASCULATURE OF THE LAD AND THE END OF THE FLOPPY TIP DID APPEAR TO PROLAPSED AND TWISTED UPON ITSELF. I SUSPECT THAT SPASM LED TO THE ENTRAPMENT OF THIS WIRE. IN CASES SUCH AS THESE, NITRATES MAY BE OF BENEFIT; FURTHERMORE, THE BALLOON MAY NEED TO BE ADVANCED INTO THE DISTAL MOST ASPECT OF THE VESSEL AND THE ATTEMPT TO PROVIDE FURTHER SUPPORT AND HOPEFULLY AVOID FRACTURES LIKE OCCURRED IN THIS CASE. I SEE NO OTHER ANATOMICAL REASON SPECIFICALLY CALCIFICATION, ANGULATION, TORTUOSITY THAT MAY HAVE LEAD TO THIS. FURTHERMORE, THERE WAS APPROPRIATE GUIDE CATHETER POSITIONING AND THERE WERE NO STENTS TO ENTRAP THIS WIRE OR OTHER HARDWARE THAT MAY HAVE LED TO THE STRUCTURAL FAILURE OF THE WIRE. IN CONCLUSION, I DO BELIEVE THAT DISTAL POSITIONING OF THE WIRE IN MICROVASCULATURE MAY HAVE LED TO SPASM OF THE DISTAL VESSEL WHICH ENTRAPPED THE WIRE AND LED TO IT'S FAILURE.' THE REPORTED FAILURE BY THE CUSTOMER AS 'GUIDEWIRE - WITHDRAWAL DIFFICULTY-FROM VESSEL' COULD NOT BE EVALUATED DUE TO THE NATURE OF THE COMPLAINT. THE REPORTED FAILURE BY THE CUSTOMER AS 'DISTAL TIP - FRACTURED-SEPARATED/IN PATIENT' WAS CONFIRMED BASED ON THE RECEIVED CONDITION OF THE DEVICE. THE EXACT CAUSE OF THE REPORTED ISSUES BY CUSTOMER AS WELL AS THE COIL UNRAVELING CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE SEM RESULTS AND THE EVENT DESCRIPTION SUGGESTED THAT PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THE FAILURES AS REPORTED. 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 THAT COULD BE CONTRIBUTED TO THE EVENTS AS REPORTED, THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RE-STERILIZED. THE GUIDEWIRE WAS NOT REMOVED FROM THE DISPENSER BY THE FLOPPY END AND WAS NOT NOTED TO BE KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE GUIDEWIRE WAS RE-SHAPED BY THE PHYSICIAN J-TIP OFF THE FLOPPY PART WITH A NEEDLE. THERE WAS NO REPORTED DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVED NORMALLY WITH GOO TORQUE RESPONSE. THE DISTAL TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO REPORTED RESISTANCE/FRICTION DURING INSERTION BUT THERE WAS DURING WITHDRAWAL INTO THE GUIDING CATHETER. THE WIRE KINKED DURING USE BUT IT WAS THE FLOPPY END WHICH WAS NOT DAMAGED. THE WIRE WAS NOT ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT AND REMAINED IN A PROLAPSED POSITION DURING TREATMENT OF THE LESION. THE WIRE WAS POSITIONED IN THE DISTAL VASCULATURE BUT DID NOT REPEATEDLY PROLAPSE DURING PLACEMENT. THE WIRE DID NOT BECOME FIXED OR CAUGHT IN THE LESION BUT DID IN THE DISTAL VESSEL. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE AND WAS REMOVED INTACT FROM THE PATIENT. THE PATIENT'S CURRENT STATUS IS GOOD. FILMS AND PROCEDURAL LOG/PHYSICIAN'S DICTATED SUMMARY ARE AVAILABLE FOR REVIEW. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. 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 THE PROCEDURE, WHILE TRYING TO PULL THE SGW ATW .014 STR FLOPPY 195CM GUIDEWIRE WIRE OUT, THE OPERATOR FELT THAT THE WIRE WAS STUCK. THEY NEEDED TO ACTIVATE A GREAT DEAL OF FORCE IN ORDER TO GET THE WIRE TO MOVE. THE WIRE THAN SPLIT AND UNDER SCREENING IT SHOWN THAT THE MAIN PART OF THE WIRE STAYED IN THE LEFT ANTERIOR DESCENDING/LAD AND THE PART THAT SPLIT ENTERED THE DIAGONAL BRANCH. THE HEALTH CARE PROFESSIONAL/HCP (HEAD OPERATOR) USED A PTT WIRE IN ORDER TO REMOVE THE ATW GUIDEWIRE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS PROLONGED APPROXIMATELY THIRTY (30) MINUTES DUE TO THE REPORTED EVENT. ADDENDUM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TARGET LESION WAS THE MID LAD. THE LESION WAS REPORTED TO BE A 100% STENOSIS-STEMI AND WAS NOT A CHRONIC TOTAL OCCLUSION/CTO. A DRILLING OR JACK-HAMMER TECHNIQUE WAS NOT USED-ANOTHER WIRE WAS INSERTED/PTT. THE ATW GUIDEWIRE (COMPLAINT PRODUCT) BECAME STUCK IN THE DISTAL VESSEL TYPE A LAD AND NOT THE LESION. THE EVENT OCCURRED POST-BALLOONING PRIOR TO STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98603 ATW GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R PTT GUIDEWIRE, LEGEND BC, BMS STENT