BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3110781 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03103
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MANUFACTURER: THERE WAS CONTRAST IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. THERE WERE NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE REPORTED BALLOON BURST WAS CONFIRMED; HOWEVER, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERIPHERALLY INSERTED CENTRAL CATHETER LINE PLACEMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE LATERAL SUBCLAVIAN ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. DURING THE FIRST INFLATION AT 2-3 ATM WITH THE DURATION OF 2-3 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERIPHERALLY INSERTED CENTRAL CATHETER LINE PLACEMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE LATERAL SUBCLAVIAN ARTERY. A 3.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. DURING THE FIRST INFLATION AT 2-3 ATM WITH THE DURATION OF 2-3 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211972 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031302010 15916875

    Patients

    Seq Age Sex Outcome Treatment
    1