BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS 120 GUIDE WIRE

    MDR report key: 2840706 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07333
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE 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) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. DURING THE ATTEMPT TO CROSS THE CTO WITH THE PROGRESS 120 GUIDE WIRE, THE DISTAL END OF THE GUIDE WIRE SEPARATED. NO ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION, AS THE TIP OF THE WIRE WAS STUCK IN THE CTO. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS PUT ON MEDICAL MANAGEMENT. NO ADVERSE PATIENT SEQUELA WAS REPORTED. 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 120 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2031301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other