BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 2061189 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01310
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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)

    Additional Manufacturer Narrative · 1

    DEVICE AVAIL. FOR EVAL CHANGED FROM NO TO YES. BRAND NAME CORRECTED FROM EXPRESS RENAL SD TO EXPRESS VASCULAR SD. COMMON DEVICE NAME CORRECTED FROM STENT, RENAL TO CATHETER, BILIARY, DIAGNOSTIC. PRODUCT CODE CORRECTED FROM NIN TO FGE. PMA# OR 510K# CORRECTED FROM P060006 TO SIMILAR. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THIS DEVICE IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE STENT DAMAGE OCCURRED. AN EXPRESS RENAL SD STENT DELIVERY SYSTEM WAS SELECTED AND WHILE CROSSING THE LESION STENOSIS THE STENT KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937917515900 13166274

    Patients

    Seq Age Sex Outcome Treatment
    1