BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 2223545 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03444
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE GUIDE WIRE WAS RETURNED IN THREE PIECES, THE DISTAL SEGMENT IS STRETCHED TO AN APPROXIMATE LENGTH OF 20.7CM; THE MIDDLE SEGMENT IS STRETCHED TO AN APPROXIMATE LENGTH OF 81.5CM, THE PROXIMAL SEGMENT PRESENTS AN OVERALL LENGTH OF 180.35CM FROM THE PROXIMAL ASPECT OF THE SAFETY RIBBON WIRE SEPARATION AND A FINISHED DIAMETER OF .03445¿ TO .03450¿. A GAGE BUSHING PASSED OVER THE LENGTH OF THE PROXIMAL SPECIMEN SEGMENT. THE SPECIMEN PRESENTS TWO FRACTURES OF THE OUTER COILING WIRE AND A FRACTURE OF THE SAFETY RIBBON WIRE NEAR THE DISTAL WELD MASS. ALL THREE SEGMENTS OF THE OUTER COIL WIRE PRESENT EXTENSIVE STRETCH DAMAGE AND INDICATIONS OF COMBINED LOAD TENSILE AND TORSION LOADING FRACTURE OF THE COILING WIRE AT THE SEPARATION OF THE DISTAL SEGMENT FROM THE MIDDLE SEGMENT; AND MECHANICAL SHEAR CUT SEPARATING THE MIDDLE SEGMENT FROM THE MAIN BODY OF THE DEVICE. APPROXIMATELY 19.30CM OF THE SAFETY RIBBON WIRE IS EXTENDING THROUGH THE COIL WRAPS APPROXIMATELY 8.8CM PROXIMAL OF THE PROXIMAL COIL WIRE FRACTURE SITE WITH APPROXIMATELY 5.0CM OF THE CORE WIRE PROTRUDING THROUGH THE COIL WRAPS APPROXIMATELY 1.5CM PROXIMAL OF THE PROXIMAL COIL WIRE FRACTURE. THE BULK OF THE SPECIMEN PRESENTS NUMEROUS BENDS OF VARYING SEVERITY SCATTERED OVER THE LENGTH OF THE COIL SEGMENTS; SAFETY RIBBON WIRE PRESENTS BENDS/KINKS LOCATED 0.05CM, 0.35CM AND 14.70CM FROM THE PROXIMAL ASPECT OF THE FRACTURE AND THE CORE WIRE PRESENTS MULTIPLE BENDS OVER THE DISTAL 0.35CM. THE SAFETY RIBBON WIRE FRACTURE PRESENTS INDICATIONS OF TENSILE OVERLOAD. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. ALL JOINTS APPEAR 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE OF A ARTERIOVENOUS FISTULA THE TIP OF A GUIDE WIRE UNRAVELED. THE MILDLY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT ARM FISTULA. A (B)(4) STARTER GUIDE WIRE ADVANCED THROUGH A 7F SUPER SHEATH. DURING USE THE STARTER GUIDE WIRE SHREDDED AND SEEMED TO UNWRAP WHILE IN THE PATIENT'S RIGHT ARM. THE GUIDE WIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. DEVICE ANALYSIS REVEALED TWO FRACTURES OF THE OUTER COILING WIRE AND A FRACTURE OF THE SAFETY RIBBON WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001491471 0001803620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INTRODUCER SHEATH, 7F SUPER SHEATH