BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 5316619 · Received December 21, 2015

    Report

    Report Number
    3008853977-2015-00521
    Event Type
    Injury
    Date Received
    December 21, 2015
    Date of Event
    November 27, 2015
    Report Date
    November 30, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE PLATINUM DISTAL TIP WAS INTACT AND WAS NOT DETACHED, SEPARATED OR BROKEN; HOWEVER, THE GUIDEWIRE WAS RECEIVED IN TWO FRAGMENTS: THE PROXIMAL FRAGMENT WAS MEASURED TO BE APPROXIMATELY 53.5CM IN LENGTH AND THE DISTAL FRAGMENT WAS APPROXIMATELY 151.0CM IN LENGTH. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE WAS TORQUED FIRST AND THEN SEPARATED. THE GUIDEWIRE WAS BENT ON SEVERAL PLACES ALONG ITS LENGTH. THE GUIDEWIRE WAS ALSO BENT ON SEVERAL PLACES ALONG ITS DISTAL SECTION WHICH APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCT. THE CAUSE FOR THE REPORTED AND THE OBSERVED BREAKS COULD NOT BE DEFINITIVELY DETERMINED. IN ADDITION, THE GUIDEWIRE¿S POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED AND IT WAS FOUND TO BE SCRAPED OFF JUST PROXIMAL AND DISTAL TO THE FRACTURE SITE. THE PTFE WAS ALSO SCRAPED OFF AT 37.5 FROM ITS PROXIMAL END. THE CAUSE FOR THE SCRAPED/PEELED PTFE COATING ON THE PROXIMAL SECTION IS LIKELY RELATED TO THE TORQUE DEVICE. PER THE DEVICE DIRECTIONS FOR USE (DFU): ¿EXCESSIVE TIGHTENING OF THE TORQUE DEVICE ONTO THE WIRE MAY RESULT IN ABRASION OF THE COATING OF THE WIRE.¿ SINCE THE DEVICE DFU PRECAUTIONS AGAINST THIS, THE CAUSE FOR THE OBSERVED SCRAPED/PEELED PTFE COATING ON THE PROXIMAL SECTION IS LIKELY RELATED TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, 3 MILLIMETERS OF THE PLATINUM TIP OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE INSIDE THE BASILAR ARTERY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RECOVER THE BROKEN PIECE USING A UNSPECIFIED RETRIEVABLE DEVICE. A SURGICAL DELAY WAS REPORTED; HOWEVER, THERE WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, 3 MILLIMETERS OF THE PLATINUM TIP OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE INSIDE THE BASILAR ARTERY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RECOVER THE BROKEN PIECE "ON HIS OWN." A SURGICAL DELAY WAS REPORTED; HOWEVER, THERE WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840526 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 17309051

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention