BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW GUIDEWIRE

    MDR report key: 2469950 · Received February 27, 2012

    Report

    Report Number
    1016427-2012-00022
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DISTAL PORTION OF THE 195 CM. SGW ATW .014 J FLOPPY GUIDEWIRE BROKE DURING REMOVAL WITHOUT APPARENTLY BECOMING STUCK. THE LESION WAS REPORTED TO BE: CALCIFIED, WITH 95 % DISEASE OF THE PROXIMAL SEGMENT. THE ATW GUIDEWIRE WAS PLACED IN THE DISTAL CIRCUMFLEX AND ANOTHER GUIDEWIRE/BMW WAS PLACED IN THE OBTUSE MARGINAL (OM) ARTERY. THE TARGET LESION WAS LOCATED AT THE BIFURCATION IN THE DISTAL CIRCUMFLEX AND OM. THE PHYSICIAN TRIED TO CROSS THE BIFURCATION LESION FOR BALLOON PREDILATATION TO THE OM WITHOUT SUCCESS. AT THIS POINT, IT WAS DECIDED TO REMOVE THE ATW WIRE FROM THE DISTAL CIRCUMFLEX TO TRY TO FACILITATE DELIVERY OF THE BALLOON TO THE TARGET LESION TO THE OM BUT DURING REMOVAL, THE EDGE OF THE GUIDEWIRE BROKE AND STAYED IN THE PROXIMAL CIRCUMFLEX. A DIAGNOSTIC IMAGE OF THE LEFT CORONARY SYSTEM, AND IMAGES OF THE LOCATION OF THE WIRE SEGMENT THAT BROKE WERE RECEIVED. THERE WERE NO IMAGES SHOWING THE WIRES CROSSING THE ARTERIES OR IMAGES OF THE ATW WIRE AS IT WAS BEING PULLED BACK FOR REMOVAL. ADDITIONAL INFORMATION INDICATED THAT THE THE WIRE WAS NOT KINKED OR DAMAGED PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED. THE USER DID NOT USE "DRILLING" OR "JACK-HAMMER" TECHNIQUE TO RECANNULIZE THE VESSEL. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THERE WAS RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES DURING WITHDRAWAL. THE WIRE WAS NOT ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT AND DID NOT PROLAPSE DURING PLACEMENT. THE WIRE BECAME FIXED OR CAUGHT IN THE LESION DURING WITHDRAWAL. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. LAKE REGION LOT NUMBER 10038471 WHICH IS CORDIS LOT NUMBER F0811046. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10038471. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL LIMITED ON AUGUST 29, 2011. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. 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. WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. THE INFORMATION AVAILABLE FOR REVIEW SUGGESTS THAT PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. BASED ON THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DISTAL PORTION OF THE 195 CM. SGW ATW .014 J FLOPPY GUIDEWIRE BROKE DURING REMOVAL WITHOUT APPARENTLY BECOMING STUCK. THE TARGET LESION WAS A BIFURCATED LESION OF THE DISTAL CIRCUMFLEX. THE LESION WAS REPORTED TO BE: CALCIFIED, WITH MODERATE DISEASE OF THE PROXIMAL SEGMENT. THE ATW GUIDEWIRE WAS PLACED IN THE DISTAL CIRCUMFLEX AND ANOTHER GUIDEWIRE/BMW WAS PLACED IN THE OBTUSE MARGINAL (OM) ARTERY. THE PHYSICIAN TRIED TO CROSS/ACCESS THE TARGET LESION FOR PRE-DILATION BUT WAS NOT SUCCESSFUL. THE PHYSICIAN AT THIS POINT DECIDED TO REMOVE THE ATW GUIDEWIRE TO FACILITATE ACCESS WITH A BALLOON CATHETER WHEN THE PRODUCT ISSUE OCCURRED. THE BROKEN DISTAL PORTION OF THE GUIDEWIRE REMAINED IN THE PROXIMAL CIRCUMFLEX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0811046

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R