BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2141566 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02484
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINIATION OF THE RETURNED DEVICE REVEALED WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON 4 MM FROM THE DISTAL EDGE OF THE DISTAL MARKERBAND. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80 PERCENT STENOSED TARGET LESION WAS LOCATED IN THE LEFT CAROTID BULB. THE 6.0MM X 20/135 STERLING, MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR POSTDILATION. ON THE FIRST INFLATION THE BALLOON REACHED 2 ATMS AND RUPTURED. IT WAS REPORTED THAT THE BALLOON LEAKED CONTRAST. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80 PERCENT STENOSED TARGET LESION WAS LOCATED IN THE LEFT CAROTID BULB. THE 6.0MM X 20/135 STERLING, MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR POSTDILATION. ON THE FIRST INFLATION THE BALLOON REACHED 2 ATMS AND RUPTURED. IT WAS REPORTED THAT THE BALLOON LEAKED CONTRAST. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031602010 13614777

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR