BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX NITINOL GUIDEWIRE

    MDR report key: 8393931 · Received March 6, 2019

    Report

    Report Number
    2182208-2019-00436
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 22, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    UDI-DI
    00821684058121
    PMA / PMN Number
    K040345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE DEVICE IT WAS DISCOVERED THAT THE WIRE WAS NOT CONSISTENT WITH A NITREX WIRE (NOT WHOLEY WIRE AS PREVIOUSLY REPORTED).THE WIRE CONSISTED OF A BLACK COATED STAINLESS STEEL CORE WIRE JOINED TO A GREEN PTFE COATED STAINLESS STEEL CORE WIRE. THE DISTAL TIP REGION WAS NOT VISIBLE, IN THAT IT WAS CONSTRAINED WITHIN THE CATHETER TUBING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE PRESENTS AN OVERALL LENGTH OF 299.10CM DUE TO THE CORE WIRE FRACTURE, A COIL LENGTH STRETCHED TO APPROXIMATELY 5.25CM, A SHAFT DIAMETER OF .01300¿ TO .01305¿, AND A FINISHED COIL DIAMETER OF .01300¿ TO .01340¿. A GAGE BUSHING CERTIFIED TO BE .0140¿ PASSED OVER THE LENGTH OF THE SPECIMEN TO THE PROXIMAL ASPECT OF THE CORE DAMAGE, WITH NO MORE EFFORT THAN THE MASS OF THE BUSHING SLIDING DOWN THE WIRE SHAFT UNAIDED, EXCEPT BY GRAVITY. THE SPECIMEN PRESENTS FRACTURES OF THE CORE AND COIL WIRES. THE COIL WIRE PRESENTS INDICATIONS OF TENSILE OVERLOAD WITH TORSIONAL LOADING AND STRETCH DAMAGE FROM THE PROXIMAL COIL TO CORE WIRE JOINT. THE CORE WIRE PRESENTS SPIRAL BEND DAMAGE OVER THE 1.50CM IMMEDIATELY PROXIMAL OF THE FRACTURE. THE CORE WIRE FRACTURE PRESENTS INDICATIONS OF LOW CYCLE BENDING FATIGUE OVERLOAD WITH TENSILE LOADING. THE DISTAL TIP JOINT AND AN INDETERMINATE AMOUNT OF COIL AND CORE WIRE IS MISSING FROM THE SPECIMEN DEVICE. THE PROXIMAL JOINT APPEARS CORRECT AND INTACT. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. BASED ON THE INFORMATION PROVIDED AND THE EVIDENCE PRESENTED, IT APPEARS THAT CLINICAL AND/OR PROCEDURAL FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF THE DEVICE IT WAS DISCOVERED THAT THE WIRE WAS NOT CONSISTENT WITH A WHOLEY WIRE. THE WIRE CONSISTED OF A BLACK COATED STAINLESS STEEL CORE WIRE JOINED TO A GREEN PTFE COATED STAINLESS STEEL CORE WIRE. THE DISTAL TIP REGION WAS NOT VISIBLE, IN THAT IT WAS CONSTRAINED WITHIN THE CATHETER TUBING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NITREX NITINOL GUIDEWIRE TO TREAT A LESION IN THE MID POPLITEAL ARTERY WITH LITTLE TORTUOSITY AND MODERATE CALCIFICATION A PATIENT. THE VESSEL WAS NOT PREDILATED OR POST DILATED. IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THAT TIP DETACHED / TIP DAMAGE OCCURRED. GUIDEWIRE PROLAPSED DID NOT OCCUR CAUSING TIP DAMAGE OR EMBOLIZATION DURING THE PROCEDURE. THE PHYSICIAN WAS TRYING TO NAVIGATE AND CROSS THROUGH POP ARTERY. IT WAS NOTICED THAT THE WIRE LOOKED LIKE IT ¿J¿D¿ UNDER FLUORO AND THE PHYSICIAN SAID SOME WAS NOTED RESISTANCE SO PULLED WIRE. A SECTION OF WIRE THAT DETACHED WAS STUCK IN CXI SUPPORT CATHETER. THE CATHETER AND DETACHED WIRE WERE REMOVED WITH NO ISSUE. PHYSICIAN SELECTED NEW WIRE AND CONTINUED PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190629 NITREX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC, INC. 11112032 00821684058121

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR