BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER LS GUIDE WIRE

    MDR report key: 2231971 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06105
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    September 21, 2010
    Report Date
    August 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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 WIRE AS DESCRIBED. ANY ADDITIONAL ATTEMPTS TO RETRACT THE WIRE IN THIS TRAPPED STATE WOULD EXCEED DESIGN LIMITS AND CAUSE THE REPORTED SEPARATION. IN THIS CASE, IT IS UNKNOWN WHEN THE GUIDE WIRE SEPARATED. THE GUIDE WIRE WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED IN THE INVESTIGATION. REPORTEDLY, THE SEPARATED PORTIONS OF THE GUIDE WIRE WERE SURGICALLY REMOVED THE NEXT DAY. 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A DIAGNOSTIC PROCEDURE WAS PERFORMED TO COMPLETE ARTERIAL CANNULATION IN THE RIGHT RADIAL ARTERY. THE WHISPER GUIDE WIRE WAS USED SUCCESSFULLY IN THE PROCEDURE. ON (B)(6) 2011, THE PATIENT ARRIVED AT THE HOSPITAL WITH PAIN AT THE WRIST. X-RAY NOTED TWO FRAGMENTS OF GUIDE WIRE, WHICH WERE 5 CM AND 3 CM LONG; THEREFORE, THE FRAGMENTS WERE SURGICALLY REMOVED THE NEXT DAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS REPORTEDLY DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER LS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 0072101

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R