BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THRUWAY GUIDE WIRE

    MDR report key: 3000493 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01398
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K022813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: AS RECEIVED, THE SPECIMEN CONSISTS OF ONE-1 EACH CLINICALLY USED, DAMAGED 190-018 SHORT TAPER G.W. DEVICE; RETURNED COILED, LOOSE DOUBLE-BAGGED WITHIN ¿ZIP-LOCK¿ STYLE POLY BIOHAZARD POUCHES. NO OTHER ORIGINAL PACKAGING OR OTHER DEVICES INVOLVED IN THE REPORTED EVENT IS INCLUDED. AS RECEIVED, THE SPECIMEN PRESENTS AN OVERALL LENGTH OF 187.70CM FROM THE PROXIMAL ASPECT OF THE CORE WIRE FRACTURE, THE COIL IS STRETCHED TO AN INDETERMINATE LENGTH, A COATED DIAMETER OF .01720 TO .01725 AND A FINISHED COIL DIAMETER OF .01715. THE PLACEMENT, SPACING AND WIDTH OF THE DEPTH MARKER BANDS APPEAR CORRECT. THE SPECIMEN PRESENTS INDICATIONS OF THE DISTAL TIP COMING UNDER CONSTRAINT, AND DURING THE WITHDRAWAL OF THE DEVICE, SUSTAINING A TENSILE OVERLOAD WITH SHEAR LOADING OF THE CORE WIRE 2.59CM DISTAL OF THE PROXIMAL COIL TO CORE WIRE SOLDER JOINT, FOLLOWED BY TENSILE LOADING OF THE COIL WIRE UNTIL A TENSILE OVERLOAD WITH TORSIONAL LOADING OCCURRED. THE DISTAL TIP COIL TO CORE SOLDER JOINT AND AN INDETERMINATE AMOUNT OF COIL AND CORE WIRE ARE MISSING AND UNACCOUNTED FOR IN THE SUPPORTED DOCUMENTATION. THE SPECIMEN ALSO PRESENTS EXTENSIVE BEND/KINK DAMAGE OF VARYING SEVERITY SCATTERED OVER THE LENGTH OF THE DEVICE BEGINNING AT THE PROXIMAL ASPECT OF THE FRACTURE AND EXTENDING TO THE THREADED PROXIMAL END. THE COATED PORTION OF THE WIRE SHAFT PRESENTS SCATTERED REGIONS OF SCRAPED PTFE COATING. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. ASIDE FROM LIGHT COLORED DEPOSITS ON THE JOINT, THE PROXIMAL JOINT APPEARS TO BE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NON-DESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT AT WITHDRAWAL AFTER A TREATMENT PROCEDURE THE THRUWAY GUIDE WIRE WAS KINKED. THE DEVICE APPEARED NORMAL BEFORE THE PROCEDURE. BUT DURING THE WITHDRAWAL, THE DEVICE BLOCKED AND EMERGED KINKED, STRETCHED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER RETURNED PRODUCT ANALYSIS REVEALED THAT THE CORE WIRE AND THE DISTAL TIP WERE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103817 THRUWAY GUIDE WIRE WIRE, GUIDE, CATHETER DQX LAKE REGION MEDICAL M001492791 0010092050

    Patients

    Seq Age Sex Outcome Treatment
    1