BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 3050312 · Received March 13, 2013

    Report

    Report Number
    3006010712-2013-00009
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH HISTORY REVIEW DEMONSTRATED NO INDICATION OF MFG RELATED DEFECTS ON THE GUIDEWIRE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE WAS MANUFACTURED TO SPECIFICATION. IT WAS STATED IN THE INCIDENT REPORT THAT DURING ADVANCEMENT OF THE GUIDE WIRE, AFTER RESISTANCE WAS MET, THE PHYSICIAN CONTINUED TO ADVANCE AND TORQUE THE GUIDE WIRE. THE KINK IS THOUGHT TO HAVE OCCURRED DURING ADVANCEMENT OF THE GUIDEWIRE. THE PHYSICIAN CONTINUED TO PUSH AND TORQUE THE WIRE FORWARD AND WHEN THE GUIDEWIRE FAILED TO CROSS THE LESION, AN ATTEMPT WAS MADE TO RETRACT THE GUIDEWIRE. IT IS AT THIS POINT THAT THE PHYSICIAN FOUND THAT THE GUIDEWIRE BECAME STUCK IN THE CATHETER. ATTEMPTS TO RETRACT THE GUIDEWIRE FROM THE CATHETER MAY HAVE CONTRIBUTED TO THE BRANCHING OF THE CATHETER AS NOTED IN IMAGE 3. KINKING OF THE GUIDEWIRE IS LIKELY TO CAUSE DIFFICULTY WITH REMOVING THE GUIDEWIRE FROM THE CATHETER. AS PREVIOUSLY MENTIONED, THE DIRECTIONS FOR USE (DFU) STATE THAT "A GUIDE WIRE IS A DELICATE INSTRUMENT AND MUST NOT BE ADVANCED, WITHDRAWN, OR TORQUED IF RESISTANCE IS MET." THE CATHETER DIRECTIONS FOR USE THAT WERE RETURNED WITH THE COOK MEDICAL CXI CATHETER PACKAGING WERE ALSO REVIEWED ((B)(4)). THE DFU STATES "THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION". THE INCIDENT REPORT DOES NOT INDICATE APPROPRIATE STEPS WERE TAKEN TO REDUCE OR REMOVE ANY OBSTRUCTION. IT IS LIKELY THAT THE ANATOMY CONDITIONS ALSO PRESENTED DIFFICULTIES FOR THE USER WHEN ATTEMPTING TO CROSS THE TARGET LESION. IT IS STATED IN THE INCIDENT REPORT THAT RESISTANCE WAS EXPERIENCED WHEN TRYING TO ADVANCE THE WIRE THROUGH THE HIGHLY CALCIFIED AND MILDLY TORTUOUS TARGET LESION. IF THE GUIDEWIRE WAS BEING MANIPULATED WITH ENOUGH FORCE IN ATTEMPT TO CROSS THE HIGHLY CALCIFIED LESION IT MAY HAVE CAUSED THE GUIDEWIRE TO PROLAPSE AND KINK. KINKING OF THE WIRE DURING USE IS AN EXPECTED POTENTIAL CHALLENGE OF INTRAVASCULAR PROCEDURES AND MAY BE CAUSED BY ROBUST USER HANDLING OR DUE TO ADVANCEMENT THROUGH CHALLENGING ANATOMY. THEY ARE ASSOCIATED WITH LOW PT EFFECTS SEVERITIES AND ARE LOW RISK. THE FORMATION OF A KINKED WIRE IS NOT UNCOMMON AS DEVICES INTERACT DURING INTERVASCULAR PROCEDURES AND IS NOT LIKELY TO RESULT IN AN ADVERSE PT IMPACT. IN THIS CASE, THE GUIDEWIRE AND CATHETER WERE REMOVED AS A UNIT WITHOUT DIFFICULTY OR SURGICAL INTERVENTION. BASED UPON CONSIDERATION OF THIS AND THE FACT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION, NO FURTHER ACTION IS WARRANTED AT THIS TIME. WE WILL CONTINUE TO MONITOR POST MARKET SURVEILLANCE FEEDBACK FOR ANY NEGATIVE TRENDS IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR RE-CANALIZATION OF THE HEAVILY CALCIFIED, MILDLY TORTUOUS, FEMORAL ARTERY, RETROGRADE FEMORAL ACCESS WAS OBTAINED. A .018 HT CONNECT GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION. AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE; HOWEVER, THE GUIDE WIRE KINKED WHICH PROHIBITED THE GUIDE WIRE FROM PASSING THROUGH THE 4 F INTRODUCER SHEATH WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. AN UNSPECIFIED GUIDE WIRE WAS USED AND THE PROCEDURE WAS ULTIMATELY CONCLUDED SUCCESSFULLY. THERE WAS NO ADVERSE PT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106689 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-09 10198922

    Patients

    Seq Age Sex Outcome Treatment
    1 Other