BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2090371 · Received May 16, 2011

    Report

    Report Number
    2134265-2011-01894
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE (B)(4) RELATES TO COMPONENT (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, BALLOON DEFLATION ISSUES WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE DENOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 100/135 STERLING OTW BALLOON CATHETER WAS SELECTED AND THE BALLOON WAS INFLATED, HOWEVER, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNSPECIFIED. MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL. THE BALLOON SHAFT WAS "TRANSECTED"; HOWEVER, THE BALLOON STILL DID NOT DEFLATE. THE BALLOON WAS REMOVED INFLATED AND THE PROCEDURE WAS CONCLUDED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032501010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER SHEATH, 5F 11CM TERUMO| GUIDE WIRE, 0.018 THRUWAY