BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2012462 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00707
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT PRODUCT WAS NOT RETURNED TO BSC FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 AN UNSPECIFIED TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNKNOWN ANATOMICAL LOCATION. DURING INFLATION OF A STERLING BALLOON CATHETER, THE BALLOON "DID NOT INFLATE ALL THE WAY". AS THE DEVICE WAS PULLED BACK, THE BALLOON CAUGHT ON THE CALCIUM AND BROKE OFF INSIDE THE PATIENT'S ANATOMY. THE DETACHED BALLOON WAS REMOVED OUTSIDE THE PATIENT. 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 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other