BEUDAMED
    FDA Adverse Event Injury Summary report: N

    014 HT WINN GUIDE WIRE

    MDR report key: 2120634 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04126
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101648
    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 INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT WAS REPORTED THAT LESION SITE WAS HEAVILY CALCIFIED AND CHRONICALLY TOTALLY OCCLUDED (CTO), WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES CROSSING. ALTHOUGH THE GUIDE WIRE WAS NOT RETURNED FOR INVESTIGATION, TYPICALLY A SEPARATION OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. A WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED, WHICH IN THIS CASE, APPEARS TO HAVE BEEN WITHIN THE CHRONICALLY TOTALLY OCCLUDED LESION. IT MAY BE POSSIBLE THAT TORQUING THE WIRE WITH THE TIP TRAPPED WITHIN THE CTO CAUSED THE TIP TO DETACH. TO ENSURE TIP SEPARATION DOES NOT OCCUR AS A RESULT OF MANUFACTURING, A TIP PULL TEST IS PERFORMED ON EACH WIRE TO ENSURE THE TIP IS PROPERLY ATTACHED. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY THE PRODUCT QUALITY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION TO SUGGEST A LOT SPECIFIC PRODUCT DEFICIENCY. OVERALL, THE REPORTED FAILURE TO CROSS AND TIP SEPARATION APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE HEAVILY CALCIFIED RIGHT POPLITEAL ARTERY, A WINN 200 GUIDE WIRE WAS TORQUED AND TURNED WHILE ATTEMPTING TO ADVANCE THROUGH THE CHRONICALLY TOTALLY OCCLUDED (CTO) LESION. DURING THIS PROCESS, APPROXIMATELY 1CM OF WIRE BROKE OFF INTO THE PATIENT. A STENT WAS PLACED TO EMBED THE WIRE INTO THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 014 HT WINN GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0080401

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention