BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIOCE GUIDEWIRE

    MDR report key: 1862303 · Received October 8, 2010

    Report

    Report Number
    2134265-2010-04444
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE WAS RECEIVED FRACTURED AND IN TWO SEGMENTS. THE DISTAL SEGMENT WAS 108CM IN LENGTH AND THE PROXIMAL SEGMENT MEASURED 73CM IN LENGTH. KINKS WERE OBSERVED ON BOTH WIRE SEGMENTS. THE DISTAL WIRE SEGMENT WAS KINKED 6CM FROM THE DISTAL TIP AND THE PROXIMAL SEGMENT WAS KINKED 29CM FROM THE PROXIMAL END. THE OD OF THE WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A SEM ANALYSIS OF THE FRACTURE SITE REVEALED THAT THE FRACTURE OCCURRED WHERE THE INNER CORE WIRE WAS INSERTED INTO THE OUTER TUBE WITHIN THE GROUND PORTION OF THE WIRE. THE DISTAL OUTER TUBE WALL WAS SPLIT OPEN WITH ROLLED OVER INNER WALLS. THE FRACTURE SURFACE EXHIBITED ELONGATED DIMPLE RUPTURES IN TEAR. THE INNER CORE WIRE EXHIBITED AN ANGLED FRACTURE SURFACE SHOWING CRACKS / SPLIT MATERIAL AND ELONGATED DIMPLED RUPTURES IN TEAR. NO MATERIAL ANOMALIES WERE NOTED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATERIOGRAM DIAGNOSIS PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND NON-TORTUOUS RIGHT COMMON ILIAC ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY, A 6FR SHEATH WAS INSERTED, AND THE CHOICE GUIDE WIRE WAS ADVANCED ACROSS THE LESION. WHEN THE ARTERIOGRAM WAS COMPLETED, THE PHYSICIAN BEGAN REMOVING THE GUIDE WIRE AND NOTED THAT AS THE WIRE PASSED THROUGH THE INTRODUCER SHEATH THE WIRE "CAME APART". THE PHYSICIAN PULLED OUT THE DETACHED WIRE SEGMENT FROM THE INTRODUCER SHEATH. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADVANCING A GLIDE WIRE AND DEPLOYING AN EXPRESS LD STENT IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTERIOGRAM DIAGNOSIS PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND NON-TORTUOUS RIGHT COMMON ILIAC ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY, A 6FR SHEATH WAS INSERTED, AND THE CHOICE GUIDE WIRE WAS ADVANCED ACROSS THE LESION. WHEN THE ARTERIOGRAM WAS COMPLETED, THE PHYSICIAN BEGAN REMOVING THE GUIDE WIRE AND NOTED THAT AS THE WIRE PASSED THROUGH THE INTRODUCER SHEATH THE WIRE 'CAME APART'. THE PHYSICIAN PULLED OUT THE DETACHED WIRE SEGMENT FROM THE INTRODUCER SHEATH. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADVANCING A GLIDE WIRE AND DEPLOYING AN EXPRESS LD STENT IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTERIOGRAM DIAGNOSIS PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND NON-TORTUOUS RIGHT COMMON ILIAC ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY, A 6FR SHEATH WAS INSERTED, AND THE CHOICE GUIDE WIRE WAS ADVANCED ACROSS THE LESION. WHEN THE ARTERIOGRAM WAS COMPLETED, THE PHYSICIAN BEGAN REMOVING THE GUIDE WIRE AND NOTED THAT AS THE WIRE PASSED THROUGH THE INTRODUCER SHEATH THE WIRE "CAME APART". THE PHYSICIAN PULLED OUT THE DETACHED WIRE SEGMENT FROM THE INTRODUCER SHEATH. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADVANCING A GLIDE WIRE AND DEPLOYING AN EXPRESS LD STENT IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIOCE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H74912135011 13585502

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR