BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 2223757 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05948
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE SEPARATION MAY OCCUR WHEN THE WIRE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE GUIDE WIRE AS DESCRIBED. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. HOWEVER, AS THERE WAS NO INFORMATION AVAILABLE REGARDING THE REPORTED GUIDE WIRE SEPARATION, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A REVIEW OF THE DEVICE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL RECORDS. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND REVEALED NO OTHER INCIDENTS REPORTED FOR THIS LOT. IN SUMMARY, BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE TIP OF THE WHISPER GUIDE WIRE SEPARATED. THERE WAS NO RESISTANCE NOTED DURING USE OF THE GUIDE WIRE. THERE WAS NO IMPLANTED STENT AND NO STENOSIS DISTAL TO WHERE THE GUIDE WIRE WAS PLACED. HOWEVER, WHEN THE PHYSICIAN PULLED BACK ON THE GUIDE WIRE A BIT, HE COULD SEE UNDER FLUORO THAT THE TIP HAD DETACHED. DUE TO THE STENOSIS IN THE SFA, A SNARE COULD NOT REACH THE SEPARATED TIP, SO A BALLOON WAS USED TO OPEN THE STENOSIS UP PROXIMALLY, THEN A LASER AND A CUTTING BALLOON WERE USED TO COMPLETELY OPEN UP THE SFA. A SNARE DEVICE WAS THEN ABLE TO REACH AND REMOVE THE SEPARATED TIP FROM THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECT. THE PATIENT OUTCOME WAS GOOD. 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-TEMECULA-CT 1052601

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention OTHER: FOX HOLLOW CUTTING BALLOON