BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2202681 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05678
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL 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 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. THE LESION WAS DESCRIBED AS MODERATELY CALCIFIED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. ADDITIONALLY, IT WAS REPORTED THAT THE DISTAL PART OF THE GUIDE WIRE WAS LODGED IN A SMALL BRANCH WITH A LOOP WHICH ALSO COULD HAVE CONTRIBUTED TO THE REPORTED SEPARATION. REPORTEDLY, THE SEPARATED PORTION OF THE GUIDE WIRE WAS RETRIEVED WITH THE USE OF A SNARE DEVICE. THE REPORTED PROLAPSED TIP IS CONSISTENT WITH INTERACTION WITH THE LESION DURING THE PROCEDURE AS THERE WAS NO DAMAGE REPORTED DURING INSPECTION PRIOR TO USE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANGINA DURING THE PROCEDURE AND IT IS UNKNOWN IF THE REPORTED GUIDE WIRE BEING LOOPED IN THE SMALL BRANCH OR THE GUIDE WIRE SEPARATION CONTRIBUTED TO THE PAIN. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS A 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, PERFORMS A NON-DESTRUCTIVE TIP PULL TEST AND PERFORMS A 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 LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED IN THE INVESTIGATION. THE REPORTED PROLAPSED TIP AND GUIDE WIRE SEPARATION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATHERECTOMY OF THE SUPERFICIAL FEMORAL ARTERY WAS PERFORMED. THE NON-ABBOTT GUIDE WIRE WAS EXCHANGED FOR A BMW UNIVERSAL GUIDE WIRE. WHEN PREPARING FOR PERCUTANEOUS ANGIOPLASTY (BALLOON ANGIOPLASTY), THE DISTAL GUIDE WIRE BECAME LODGED IN A SMALL BRANCH (WITH A LOOP), THE PATIENT HAD COMPLAINED OF PAIN. THE GUIDE WIRE WAS PULLED IN AN ATTEMPT TO REPOSITION IT AND IT WAS NOTED THAT THE PROXIMAL END OF THE GUIDE WIRE CAME OUT EASILY; HOWEVER, THE DISTAL HALF OF THE GUIDE WIRE WAS LEFT PARTIALLY INSIDE THE BALLOON AND THE GUIDE WIRE WAS SEEN TO BE FRACTURED. A SNARE DEVICE WAS USED TO EXTRACT THE FRACTURED SEGMENT VIA THE SHEATH VIA AN ANTEGRADE APPROACH; HOWEVER, THE PROXIMAL PORTION OF THE FRACTURED SEGMENT BECAME LODGED IN THE AORTIC BIFURCATION, WHICH REQUIRED POPLITEAL ACCESS TO SNARE THE FRACTURED SEGMENT OF THE GUIDE WIRE SUCCESSFULLY. THE PATIENT IS DOING WELL AND IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1032871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIL CATH: CORDIS