BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014

    MDR report key: 5820941 · Received July 25, 2016

    Report

    Report Number
    3004859241-2016-00007
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 28, 2016
    Report Date
    June 28, 2016
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729187332
    PMA / PMN Number
    K934122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: ADDED. MANUFACTURING DATE: ADDED. THE DEVICE HISTORY REVIEW CONFIRMS THAT THERE WAS NO INDICATION THAT THE DEVICE, LABELING OR MANUFACTURING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. VISUAL INSPECTION OF THE SUBJECT DEVICE DISCOVERED TWO BROKEN FRAGMENTS: THE PROXIMAL PART AND DISTAL PART THAT REMAINED TO BE LOADED IN THE MICROCATHETER THAT WAS FULL OF BLOOD. THE GUIDEWIRE WAS FOUND BEND ALONG ITS LENGTH. MAGNIFIED EXAMINATION OF THE FRACTURE SITE REVEALED THAT THE CORE WIRE WAS BENT FIRST AND THEN SEPARATED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED BECAUSE OF THE CONDITION OF THE RETURNED PRODUCT. ADDITIONAL INFORMATION STATED THAT THERE WAS AN INTERMITTENT FLUSH USED DURING THE PROCEDURE AND THERE WERE CAUTIONS SPECIFIED AGAINST IT PER THE MICROCATHETER¿S DIRECTION FOR USE (DFU): ¿IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF STRYKER NEUROVASCULAR MICROCATHETERS AND TO MAINTAIN THE LUBRICITY OF THE HYDROLENE COATING SURFACE, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE STRYKER NEUROVASCULAR MICROCATHETER AND GUIDE CATHETER, AND THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. IN ADDITION, FLUSHING AIDS IN PREVENTING CONTRAST CRYSTAL FORMATION AND/OR CLOTTING ON BOTH THE INTRALUMINAL DEVICE AND INSIDE THE GUIDE CATHETER AND/OR THE MICROCATHETER LUMEN." IT WAS ALSO INDICATED THAT THE GUIDEWIRE WAS ADVANCED AGAINST FRICTION AND THAT THE CAUTION AGAINST IT WAS SPECIFIED IN THE SUBJECT DEVICE DFU: "NEVER ADVANCE THE GUIDEWIRE AGAINST EXCESSIVE RESISTANCE WITHOUT FIRST DETERMINING THE REASON FOR RESISTANCE UNDER FLUOROSCOPY. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE CATHETER AND/OR VESSEL PERFORATION". THEREFORE, BECAUSE CONTINUES FLUSH WAS NOT MAINTAINED THE DEVICE PERFORMANCE BECAME LIMITED, THAT RESULTED IN THE REPORTED FRICTION, WHICH LIKELY TO HAVE CONTRIBUTED TO THE TORSION AGAINST RESISTANCE, CAUSING THE KINK AND FRACTURE OF THE GUIDEWIRE. BASED ON THE GUIDEWIRE AND RELATED COMPLAINT MICROCATHETER DFUS, SPECIFICALLY CAUTIONING ABOUT FORCE AGAINST RESISTANCE AND CONTINUOUS FLUSH MAINTENANCE TO ACHIEVE OPTIMUM PERFORMANCE, THE CAUSE USE ERROR WAS ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS ROTATED IN ORDER TO ADVANCE THE GUIDEWIRE INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE PATIENT AND OBSERVED THAT APPROXIMATELY 50 CM OF THE PROXIMAL SECTION OF THE GUIDEWIRE WAS BROKEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE GUIDEWIRE WITH THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE WAS ROTATED IN ORDER TO ADVANCE THE GUIDEWIRE INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE GUIDEWIRE FROM THE PATIENT AND OBSERVED THAT APPROXIMATELY 50 CM OF THE PROXIMAL SECTION OF THE GUIDEWIRE WAS BROKEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE GUIDEWIRE WITH THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471579 TRANSEND EX 014 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 18419673 08714729187332

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR