BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 4892991 · Received July 6, 2015

    Report

    Report Number
    3008853977-2015-00275
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. MICROSCOPIC ANALYSIS OF THE DEVICE REVEALED THAT THE POLYMER SLEEVE WAS RIPPED AT APPROXIMATELY 5.0CM FROM ITS DISTAL END. THE CORE WIRE AND THE POLYMER SLEEVE WERE SEPARATED, THE TIP OF THE GUIDEWIRE WAS NOT RETURNED. THE POLYMER SLEEVE APPEARED TO BE SLIGHTLY STRETCHED. THE GUIDEWIRE WAS SLIGHTLY BENT ON ITS PROXIMAL SECTION. THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED AND IT WAS FOUND TO BE SCRAPPED OFF AT 22.0CM FROM ITS PROXIMAL END. SINCE THE DEVICE DIRECTIONS FOR USE (DFU) CAUTIONS THAT EXCESSIVE TIGHTENING OF THE TORQUE DEVICE MAY RESULT IN ABRASION OF THE COATING OF THE WIRE; THEREFORE, THE PTFE PEELING IS BELIEVED TO BE USER RELATED. THE GUIDEWIRE HYDROPHILIC COATING AND OUTER DIAMETER WERE CONFORMING TO ITS REQUIRED SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE ANOMALIES FOUND ON THE RETURNED DEVICES. THE DIRECTIONS FOR USE (DFU) STATES THAT EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE CATHETER AND/OR VESSEL PERFORATION." IMAGES OF THE FRACTURE SITE SHOWS EVIDENCE OF A DUCTILE FRACTURE DUE TO THE POLYMER SLEEVE STRETCHING AND COVERING THE CORE WIRE. BASED ON REVIEW OF THE INFORMATION AVAILABLE, IT IS PROBABLE THAT HANDLING OF THE DEVICE DURING THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, A ROOT CAUSE OF HANDLING DAMAGE HAS BEEN ASSIGNED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POSITIONING OF THE GUIDEWIRE (SUBJECT DEVICE) IN THE INTERNAL CAROTID ARTERY AT THE BEGINNING OF THE PROCEDURE, THE TIP BROKE OFF AND REMAINED IN THE PATIENT¿S CIRCULATION. APPROXIMATELY 7CM BROKE OFF AND WAS NOT SNARED OR PINNED AGAINST THE VESSEL WALL. THE PATIENT CONDITION RESULTING FROM THE REPORTED ISSUE WAS NORMAL, AS THE PATIENT DID NOT PRESENT A REJECTION RESPONSE. THE CURRENT PATIENT CONDITION IS NORMAL AND THE PATIENT WAS UNDER OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POSITIONING OF THE GUIDEWIRE (SUBJECT DEVICE) IN THE INTERNAL CAROTID ARTERY AT THE BEGINNING OF THE PROCEDURE, THE TIP BROKE OFF AND REMAINED IN THE PATIENT'S CIRCULATION. APPROXIMATELY 7CM BROKE OFF AND WAS NOT SNARED OR PINNED AGAINST THE VESSEL WALL. THE PATIENT CONDITION RESULTING FROM THE REPORTED ISSUE WAS NORMAL, AS THE PATIENT DID NOT PRESENT A REJECTION RESPONSE. THE CURRENT PATIENT CONDITION IS NORMAL AND THE PATIENT WAS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435215 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 16942716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other