BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIWIRE HYDROPHILIC WIRE GUIDE

    MDR report key: 3853644 · Received May 29, 2014

    Report

    Report Number
    1820334-2014-00226
    Event Type
    Injury
    Date Received
    May 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: IT HAS BEEN REPORTED THAT TWO MONTHS FOLLOWING A FAILED THROMBECTOMY PROCEDURE, THE PATIENT PRESENTED FOR SURGICAL REVISION OF THE AVG. HOWEVER, AFTER SURGERY, HE BECAME HYPOTENSIVE AND BRADYCARDIAC AND LATER DIED. THE CAUSE OF DEATH WAS ATTRIBUTED TO A PULMONARY EMBOLUS. HISTOPATHOLOGIC EVALUATION OF THE RESECTED GRAFT SHOWED THE PRESENCE OF A BASOPHILIC HOMOGENOUS POLYMER MATERIAL SURROUNDED BY GIANT CELLS WITHIN A THROMBUS. WHILE THE PATIENT EXHIBITED AN ADVERSE PHYSIOLOGICAL RESPONSE TO THE PRESENCE OF THE POLYMER THROMBECTOMY PROCEDURE. ANY EXISTING THROMBUS IS PRONE TO EMBOLI FORMATION. HOWEVER, IT IS IMPORTANT TO NOTE THAT WHILE THE CAUSE OF DEATH WAS ATTRIBUTED TO A PULMONARY EMBOLISM, IT IS UNCERTAIN WHETHER AVG THROMBOSIS DIRECTLY CAUSED THE PULMONARY EMBOLISM, SINCE THE PUBLICATION DOES NOT DESCRIBE WHAT PATHOLOGY WAS DEMONSTRATED IN THE LUNG(S). THE DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION. THROMBUS FORMATION AND EMBOLI ARE KNOWN COMPLICATIONS OF THE USE OF HIWIRE HYDROPHILIC WIRE GUIDES. FURTHERMORE, THE INSTRUCTIONS FOR USE PROVIDES DIRECTIONS FOR USE, WARNINGS, AND CAUTIONS REGARDING PROPER USE OF THIS DEVICE. SPECIFICALLY, IT STATES "USE OF ALCOHOL, ANTISEPTIC SOLUTIONS OR OTHER SOLVENTS MUST BE AVOIDED, BECAUSE THEY MAY ADVERSELY AFFECT THE SURFACE OF THE HYDROPHILIC WIRE GUIDE." "AVOID MANIPULATING OR WITHDRAWING THE HYDROPHILIC WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE THE COATING OR SHEAR THE WIRE GUIDE. A CATHETER, INTRODUCER SHEATH OR VESSEL DILATOR SHOULD REPLACE THE NEEDLE AS SOON AS THE WIRE GUIDE HAS BEEN INSERTED IN THE VESSEL." DESIGN VERIFICATION TESTING HAS BEEN CONDUCTED TO CONFIRM THE PERFORMANCE OF THE HYDROPHILIC COATING. THE RISK REMAINS ACCEPTANCE WITH INCLUSION OF THIS EVENT, DUE TO LOW OCCURRENCE AND MODERATE DETECTION. NO ADD'L ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MAN WITH END-STAGE RENAL DISEASE TREATED BY HEMODIALYSIS WAS ADMITTED AFTER HIS LEFT UPPER-EXTREMITY PROSTHETIC ARTERIOVENOUS GRAFT (AVG) CLOTTED. THE SUBSEQUENT GRAFT THROMBECTOMY PROCEDURE (IN 2012) FAILED AND THEREFORE A RIGHT FEMORAL TUNNELED DIALYSIS CATHETER WAS PLACED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR SURGICAL REVISION OF THE AVG. HOWEVER, AFTER SURGERY, HE BECAME HYPOTENSIVE AND BRADYCARDIAC AND LATER DIED. THE CAUSE OF DEATH WAS ATTRIBUTED TO A PULMONARY EMBOLUS. HISTOPATHOLOGIC EVALUATION OF THE RESECTED GRAFT SHOWED THE PRESENCE OF A BASOPHILIC HOMOGENOUS POLYMER MATERIAL SURROUNDED BY GIANT CELLS WITHIN A THROMBUS. THERE IS NO WAY OF KNOWING FOR SURE WHETHER THE PARTICULATE IN THE AVG CAME FROM A COOK DEVICE. THE AUTHORS OF THE JOURNAL ARTICLE DID OFFER A POSSIBLE SCENARIO THAT COULD HAVE RESULTED IN HC PARTICULATE FROM THE WIRE ENDING UP IN THE THROMBOSIS AVG AS FOLLOWS: THE PRESENCE OF THE POLYMER IN A CLOTTED ACCESS IN THE SECOND PATIENT SUGGESTS THAT THE HYDROPHILIC COATING SHEARED OFF AND ENTERED THE AVG LUMEN DURING THE THROMBECTOMY, THE GLIDEWIRE IS INTRODUCED INTO A GRAFT THROUGH AN 18-GAUGE NEEDLE. MANIPULATING THE GLIDEWIRE BACK AND FORTH WITHIN THE NEEDLE WILL NOT ONLY TEAR THE WIRE, BUT CAN CAUSE THE HYDROPHILIC COATING TO SHEAR OFF. BECAUSE THROMBOLYSIS FAILED, THE SHEARED POLYMER REMAINED IN THE AVG AND A FOREIGN-BODY REACTION HAD DEVELOPED. AFTER A SUBSEQUENT GRAFT THROMBECTOMY PROCEDURE FAILED, A RIGHT FEMORAL TUNNELED DIALYSIS CATHETER WAS PLACED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR SURGICAL REVISION OF AVG. HOWEVER, AFTER SURGERY, HE BECAME HYPOTENSIVE AND BRADYCARDIAC AND LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317338 HIWIRE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death