BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS 200T GUIDE WIRE

    MDR report key: 4233299 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07273
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. BASED ON A VISUAL INSPECTION 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. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED. THE GUIDE WIRE FRAGMENT REMAINED IN THE PATIENT'S VESSEL AND A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CHRONIC TOTALLY OCCLUDED (CTO) LEFT ANTERIOR DESCENDING (LAD) THE UNSPECIFIED ABBOTT GUIDE WIRE FRACTURED AND A PORTION REMAINED IN THE PATIENT'S ANATOMY. THE FINAL PATIENT OUTCOME AND TREATMENT WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712796 HI-TORQUE PROGRESS 200T GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 4032771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other