BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX GUIDEWIRE

    MDR report key: 1983800 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00126
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND DAMAGE TO THE POLY TIP. THE OVERALL LENGTH OF THE GUIDE WIRE WAS MEASURED TO BE 182CM. THE OVERALL LENGTH OF THE POLY TIP WAS MEASURED TO BE 30CM. THE DEVICE DOES NOT PRESENT A FRACTURE AT THE POLY TIP. THE TIP AND CORE WIRE ARE INTACT. THE POLY TIP DOES PRESENT APPROXIMATELY 0.2CM OF SCRAPED POLYMER IN THE MIDDLE SECTION. ALL OUTER DIMENSION MEASUREMENTS TAKEN WERE FOUND TO MEET SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED CAUSED BY OTHER DEVICE DUE TO THE INTERACTION WITH THE IMPLANTED STENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-00437. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE TIP DETACHED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 99% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ANOTHER MANUFACTURERS' GUIDE WIRE CROSSED THE LESION AND THROMBECTOMY WAS PERFORMED THREE TIMES. THE LESION WAS THEN PRE-DILATED WITH ANOTHER MANUFACTURERS' 2.0X15MM BALLOON CATHETER AT 6ATMS FOR 30 SECONDS. A 3.00X24MM LIBERTE BARE STENT WAS IMPLANTED IN ITS INTENDED LOCATION IN THE LESION AND POST-DILATED. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. IVUS WAS THEN PERFORMED WHICH SHOWED THAT THE 2ND DIAGONAL BRANCH WAS JAILED BY THE IMPLANTED LIBERTE STENT. THE PHYSICIAN WANTED TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO THE 2ND DIAGONAL TO IMPROVE BLOOD FLOW, THEREFORE, A PT GRAPHIX 182CM GUIDE WIRE WAS ADVANCED THROUGH THE LIBERTE STENT AND INTO THE 2ND DIAGONAL. AFTER THE PT GRAPHIX CROSSED INTO THE 2ND DIAGONAL, ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DETERMINED THAT BLOOD FLOW WAS "RECOVERED" AND POBA WAS NOT NECESSARY. THE PT GRAPHIX GUIDE WIRE WAS WITHDRAWN FROM THE PATIENT WITH SOME RESISTANCE. ANGIOGRAPHY WAS PERFORMED AGAIN, AT WHICH POINT THE PHYSICIAN NOTED "SOMETHING WITHIN THE IMPLANTED LIBERTE STENT". THE PT GRAPHIX WAS CHECKED OUTSIDE THE PATIENT AND IT WAS NOTED THAT APPROXIMATELY 2CM FROM THE DISTAL TIP WAS DETACHED. IT IS THOUGHT THAT THE TIP REMAINS BETWEEN THE BRANCH AND THE STENT. THE PROCEDURE WAS CONSIDERED COMPLETE AT THIS POINT. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-00437. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE TIP DETACHED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 99% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ANOTHER MANUFACTURERS' GUIDE WIRE CROSSED THE LESION AND THROMBECTOMY WAS PERFORMED THREE TIMES. THE LESION WAS THEN PRE-DILATED WITH ANOTHER MANUFACTURERS' 2.0X15MM BALLOON CATHETER AT 6ATMS FOR 30 SECONDS. A 3.00X24MM LIBERTE BARE STENT WAS IMPLANTED IN ITS INTENDED LOCATION IN THE LESION AND POST-DILATED. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. IVUS WAS THEN PERFORMED WHICH SHOWED THAT THE 2ND DIAGONAL BRANCH WAS JAILED BY THE IMPLANTED LIBERTE STENT. THE PHYSICIAN WANTED TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO THE 2ND DIAGONAL TO IMPROVE BLOOD FLOW, THEREFORE, A PT GRAPHIX 182CM GUIDE WIRE WAS ADVANCED THROUGH THE LIBERTE STENT AND INTO THE 2ND DIAGONAL. AFTER THE PT GRAPHIX CROSSED INTO THE 2ND DIAGONAL, ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DETERMINED THAT BLOOD FLOW WAS "RECOVERED" AND POBA WAS NOT NECESSARY. THE PT GRAPHIX GUIDE WIRE WAS WITHDRAWN FROM THE PATIENT WITH SOME RESISTANCE. ANGIOGRAPHY WAS PERFORMED AGAIN, AT WHICH POINT THE PHYSICIAN NOTED "SOMETHING WITHIN THE IMPLANTED LIBERTE STENT". THE PT GRAPHIX WAS CHECKED OUTSIDE THE PATIENT AND IT WAS NOTED THAT APPROXIMATELY 2CM FROM THE DISTAL TIP WAS DETACHED. IT IS THOUGHT THAT THE TIP REMAINS BETWEEN THE BRANCH AND THE STENT. THE PROCEDURE WAS CONSIDERED COMPLETE AT THIS POINT. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74914902011 0013269790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 2.0X15MM TAZUNA BALLOON CATHETER| NEOS SOFT GUIDE WIRE| 7F THROMBUSTER| LIBERTE BARE (MR) OUS 24MMX3.00 STENT