BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 SOFT TIP

    MDR report key: 3023892 · Received March 27, 2013

    Report

    Report Number
    3008853977-2013-00056
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. MICROSCOPIC INSPECTION OF THE RETURNED GUIDEWIRE FOUND THAT THE GUIDEWIRE WAS SEPARATED AT 93.5 CM FROM ITS PROXIMAL END. THE GUIDEWIRE APPEARED TO BE BENT AT THE SEPARATED SITE. THE GUIDEWIRE WAS ALSO TWISTED ON THE DISTAL SEPARATED SITE. THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED NO ANOMALIES WERE OBSERVED. THE DEVICE WAS SENT FOR ADDITIONAL ANALYSIS WHICH INCLUDED SEM (SCANNING ELECTRON MICROSCOPY). SEM ANALYSIS DETERMINED THAT THE FAILURE OCCURRED DUE TO A BENDING OVERLOAD FOLLOWED BY A FINAL TENSION OVERLOAD. BOTH SAMPLES PRESENTED FAILURES ON THE EXTERNAL WIRE WITH CORRESPONDING CHARACTERISTICS SUGGESTING MATCH BETWEEN THEM. NO MATCH ON THE INNER WIRE WAS POSSIBLE TO DETERMINE. BASED ON THE SEM ANALYSIS AND INVESTIGATION, THE FAILURE OCCURRED DUE TO A BENDING OVERLOAD FOLLOWED BY A FINAL TENSION OVERLOAD (BENT FIRST, AND THEN PUSHED OR PULLED). THE DEVICE DIRECTIONS FOR USE (DFU) WAS REVIEWED AND THE FOLLOWING WAS FOUND: "EXERCISE CARE IN HANDLING A GUIDEWIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING OR KINKING." AS WELL, PER THE 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." BECAUSE THE ISSUE OCCURRED WHEN ATTEMPTING TO INSERT THE GUIDEWIRE INTO A MICROCATHETER DURING THE PROCEDURE, THE CAUSE FOR THE REPORTED AND OBSERVED ISSUE IS BELIEVED TO BE HANDLING DAMAGE DURING USE.

    Description of Event or Problem · 1

    DURING PREPARATION, THE PHYSICIAN ATTEMPTED TO INSERT THIS GUIDEWIRE INTO A MICROCATHETER BUT THE GUIDEWIRE BROKE. THE BROKEN PART OF THE GUIDEWIRE WAS REMOVED FROM THE MICROCATHETER USING FORCEPS. THIS EVENT TOOK PLACE DURING PREPARATION AND OUTSIDE THE PATIENT. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    DURING PREPARATION THE PHYSICIAN ATTEMPTED TO INSERT THIS GUIDEWIRE INTO A MICROCATHETER BUT THE GUIDEWIRE BROKE. THE BROKEN PART OF THE GUIDEWIRE WAS REMOVED FROM THE MICROCATHETER USING FORCEPS. THIS EVENT TOOK PLACE DURING PREPARATION AND OUTSIDE THE PATIENT. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127106 TRANSEND EX 014/205 SOFT TIP WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 15614444

    Patients

    Seq Age Sex Outcome Treatment
    1