BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    MDR report key: 2083355 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01840
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    DQY
    PMA / PMN Number
    K011889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01839. IT WAS REPORTED THAT DURING AN ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, THE FORMATION OF AN AV FISTULA OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY USING A CONTRALATERAL APPROACH. TWO NON-BSC SELF-EXPANDING NITINOL STENTS HAD BEEN PREVIOUSLY IMPLANTED ON AN UNSPECIFIED DATE IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE PROXIMAL RIGHT SFA. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON-TORTUOUS RIGHT SFA PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT IN THE DISTAL SFA. THE LESION WAS NOT PRE-DILATED. A 5X40X1350 SENTINOL BILIARY STENT WAS ADVANCED AND DEPLOYED OVERLAPPING THE PREVIOUSLY IMPLANTED STENT IN THE DISTAL SFA. AN ANGIOGRAM WAS PERFORMED SHOWING THAT THE SENTINOL STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL. A 6-4/5.3/135 ULTRA-THIN SDS BALLOON CATHETER WAS SELECTED FOR POST-DILATION AND INFLATED TO 8ATMS FOR APPROXIMATELY 10 SECONDS. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THE FINAL ANGIOGRAM SHOWED THE FORMATION OF AN AV FISTULA ORIGINATING AT THE OVERLAP BETWEEN THE SENTINOL STENT AND THE PREVIOUSLY IMPLANTED STENT IN THE DISTAL SFA. DISTAL RUN OFF LOOKED GOOD. THE PHYSICIAN FELT THAT BECAUSE THE STENTS WERE COVERING THE AV FISTULA THAT IT WILL SEAL AND HEAL ON ITS' OWN. THE PROCEDURE WAS CONSIDERED COMPLETED AT THIS POINT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - GALWAY M001176280

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other