BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1860111 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04441
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K964611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE DEVICE WAS RECEIVED IN TWO PIECES; A FRAGMENT OF APPROXIMATELY 2CM AND THE REMAINDER OF THE WIRE WAS STUCK INSIDE A BALLOON CATHETER AND COULD NOT BE REMOVED. THE OUTER DIAMETER OF THE TIP FRAGMENT WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. NO MATERIAL ANOMALIES WERE NOTED. SEM LAB ANALYSIS OF THE DISTAL TIP REVEALED THE FRACTURE SURFACE EXHIBITED ELONGATED DIMPLED RUPTURES IN A TWIST OR TORSIONAL DIRECTION INDICATING THE FRACTURE OCCURRED DUE TO A TORSIONAL OVERLOAD. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE TIP BECAME DETACHED. VASCULAR ACCESS WAS OBTAINED UTILIZING A CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESIONS WERE LOCATED IN A SEVERELY TORTUOUS VESSEL OF THE UPPER ARM. THERE WERE TWO IDENTIFIED LESIONS; ONE LOCATED WITHIN A VEIN AND THE SECOND WITHIN AN ANASTOMOSED VESSEL. THE 135CM TRANSCEND GUIDE WIRE CROSSED THE LESION AND A 4MM STERLING BALLOON CATHETER WAS USED FOR DILATATION. AFTER DILATATION, THE GUIDE WIRE WAS TO BE MOVED APPROXIMATELY 5CM TO THE ANASTOMOSED LESION. PRIOR TO REACHING THE INTENDED LOCATION, THE GUIDE WIRE TIP TORE AND APPROXIMATELY 2CM WAS DETACHED. THE PATIENT UNDERWENT SURGERY IN ORDER TO REMOVE THE WIRE FRAGMENT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05880.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M001468100 13371663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENCORE 26 INFLATION DEVICE| 4MM STERLING BALLOON CATHETER| 4FR MOSQUITO INTRODUCER SHEATH