BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 1931636 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02792
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE GUIDE WIRE WAS RETURNED WITH BLOOD ON THE POLYMER AND THERE WAS NO CONTRAST VISIBLE, WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE TIP SEPARATION, AS THE CORE, COILS, AND POLYMER COATING WERE SEPARATED 22.3 CM DISTAL TO THE PROXIMAL END OF THE POLYMER. THE POLYMER WAS STRETCHED AND JAGGED AT THE SEPARATION. THE DISTAL SEPARATED PORTION WAS NOT RETURNED. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. FOR THE WIRE TO FAIL IN THIS MANNER, THE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING, OR OVER TORQUED BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY, OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. ANY ATTEMPTS TO MOVE THE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. IN THIS CASE, THE LESION WAS DESCRIBED AS CHRONICALLY TOTALLY OCCLUDED AND HEAVILY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED GUIDE WIRE TIP SEPARATION. THE WHISPER INSTRUCTIONS FOR USE (IFU) STATES: DO NOT: PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. THE REPORTED GUIDE WIRE SEPARATION, RESISTANCE, REMOVAL OF FOREIGN BODY, SURGICAL PROCEDURE, HOSPITALIZATION, AND RESPIRATORY DISTRESS APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT. MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST COUPLE OF WEEKS, THE PATIENT HAD INTERMITTENT MOTOR STALLS AND RECOVERIES. THE PATIENT HAD EXPERIENCED INCREASED BASELINE PAIN. ON (B)(6) 2010, A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THERE WAS NO EXPOSURE TO ANY SOURCES OF EMI (ELECTROMAGNETIC INTERFERENCE). THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE AND CLONIDINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS STARTED WITH A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE, BUT IT WAS NOT POSSIBLE TO CROSS THE CHRONICALLY TOTALLY OCCLUDED AND HEAVILY CALCIFIED TARGET LESION IN THE LEFT CORONARY ARTERY (LCA). THE PHYSICIAN CHANGED TO A WHISPER LS GUIDE WIRE, BUT ALSO WITH THIS GUIDE WIRE HE COULD NOT CROSS THE TARGET LESION. HE CHANGED TO THE WHISPER ES GUIDE WIRE AND IT WAS POSSIBLE TO CROSS THE LESION, BUT THE PHYSICIAN FELT RESISTANCE DURING CROSSING. AFTER SUCCESSFUL DILATATION OF THE TARGET LESION, THE PHYSICIAN WANTED TO RETRACT THE WHISPER ES GUIDE WIRE, BUT HE NOTICED DURING RETRACTING THAT THE TIP OF THE WHISPER ES GUIDE WIRE HAD SEPARATED. IT WAS DECIDED TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL TO REMOVE THE TIP BY SURGERY. THE TIP WAS SUCCESSFULLY REMOVED. AFTER THE SURGERY, THE PATIENT EXPERIENCED ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) AND IS THEREFORE STILL UNDER VENTILATION AT THE INTENSIVE CARE STATION OF THE HOSPITAL. THE PHYSICIAN STATED THE RECOVERY PROCESS IS GOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-MURRIETA 0061802

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R