BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS 80 GUIDE WIRE

    MDR report key: 2801522 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06679
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE DIFFICULTIES REMOVING THE GUIDE WIRE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PROGRESS GUIDE WIRE WAS ADVANCED; HOWEVER, THE PHYSICIAN DID NOT KNOW IF THE GUIDE WIRE WAS IN THE RIGHT LUMEN; THEREFORE, IT WAS PULLED BACK, AND RESISTANCE WAS NOTED. THE GUIDE WIRE WAS PULLED INTO THE GUIDING CATHETER, AND RESISTANCE WAS NOTED AGAIN. THE GUIDE WIRE WAS TWISTED, AND WAS ABLE TO BE REMOVED. AFTER REMOVAL, IT WAS NOTED THAT 1.5 CM OF THE TIP SEPARATED, AND WAS SEEN UNDER ANGIOGRAPHY INSIDE THE GUIDING CATHETER. A NEW GUIDE WIRE AND BALLOON CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED CLOSE TO THE DISTAL EXIT OF THE GUIDING CATHETER AND ALL DEVICES WERE REMOVED AS A UNIT. THE PROCEDURE WAS STOPPED, AND NO ADDITIONAL TREATMENT WILL BE PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PROGRESS 80 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0101101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: MULTIPURPOSE I