BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 1924669 · Received December 14, 2010

    Report

    Report Number
    3006169760-2010-00006
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED WHISPER GUIDE WIRE FOUND NO BLOOD OR CONTRAST VISIBLE WHICH IS CONSISTENT WITH A GUIDE WIRE BEING WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE, COILS, AND POLYMER COATING WERE SEPARATED, 11.3 CM PROXIMAL TO THE TIP BALL. THE POLYMER WAS STRETCHED AND JAGGED AT THE SEPARATION. THE SEPARATED PORTION WAS NOT RETURNED. THERE WERE KINKS IN THE CORE 1.5 AND 6 CM PROXIMAL TO THE TIP BALL. THE NOTED COILS SEPARATION, POLYMER COATING SEPARATION AND KINKS IN THE CORE APPEAR TO BE THE RESULT OF THE REPORTED GUIDE WIRE SEPARATION AS NO DAMAGE WAS NOTED PRIOR TO USE. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. FOR THE GUIDE WIRE TO FAIL IN THIS MANNER THE GUIDE 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 GUIDE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE TIP BY WRAPPING THE SEPARATED TIP WITH THE UNKNOWN GUIDE WIRES. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THE REPORTED GUIDE WIRE SEPARATION, AND THE NOTED SEPARATED COIL AND POLYMER, AND KINKS IN THE CORE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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. DILATATION CATHETER: SPRINTER RX/NC; GUIDE WIRE: HT FLOPPY/WHISPER; GUIDE CATH: 6F; STENT: MULTI LINK VISION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DELIVERED THE HT GUIDE WIRES (GW) IN THE DIAGONAL VESSEL AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A VISION STENT WAS SUCCESSFULLY DELIVERED AT THE MID LAD. AFTER DEPLOYMENT OF THE STENT THE HT GW LOCATED IN THE DIAGONAL VESSEL WAS JAILED BY THE STENT. THE PHYSICIAN THEN WANTED TO POST DILATE THE IMPLANTED VISION STENT. HE THEREFORE PROCEEDED TO PLACE THE WHISPER MS GW INTO THE DIAGONAL VESSEL FOR SUPPORT AND TO REMOVE THE HT GW IN THE VESSEL. UPON REMOVING THE WHISPER MS GW THE PHYSICIAN NOTED THAT THE TIP BROKE OFF. NO RESISTANCE WAS FELT DURING REMOVAL OF THE GUIDE WIRE. FLUOROSCOPY REVEALED THAT THE TIP WAS LOCATED IN THE MIDDLE OF THE DEPLOYED STENT. A NON-ABBOTT BALLOON CATHETER WAS INSERTED PAST THE TIP AND INFLATED IN AN ATTEMPT TO PULL BACK AND RETRIEVE THE TIP. AFTER THE FAILED ATTEMPT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE TIP BY WRAPPING THE SEPARATED TIP WITH THE HT GWS. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT DID NOT SUFFER ANY HEALTH EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-MURRIETA 0090901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention