BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2221023 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03545
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH BLOOD VISIBLE IN THE WIRE LUMEN. EXAMINATION OF THE DEVICE REVEALED THE DISTAL PORTION OF THE BALLOON WAS EXTENDING OVER THE TIP. THE SHAFT WAS STRETCHED AND KINKED IN NUMEROUS LOCATIONS THROUGHOUT THE ENTIRE LENGTH OF THE CATHETER. MAGNIFIED INSPECTION REVEALED THAT THE PROXIMAL BALLOON BOND WAS DETACHED/SEPARATED FROM THE SHAFT AND THE INNER SHAFT WAS DETACHED/SEPARATED 16.5CM DISTALLY FROM THE GUIDEWIRE EXIT NOTCH. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE RECEIVED CONDITION OF THE DEVICE. 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

    AGE AT TIME OF EVENT: OVER (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, DEFLATION DIFFICULTY AND BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND TORTUOUS ARTERIOVENOUS FISTULA. THE 8.0 X 60/135 (4F) STERLING BALLOON CATHETER WAS USED DURING THE TREATMENT PROCEDURE WHEN IT WAS REPORTED THAT THE BALLOON HAD TROUBLE INFLATING (NUMEROUS INFLATIONS) AND ALSO WOULD NOT DEFLATE (CONTRAST WAS NOT COMING OUT OF THE BALLOON). IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER BEING INFLATED 10-12ATMS FOR APPROXIMATELY 30 SECONDS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, DEFLATION DIFFICULTY AND BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND TORTUOUS ARTERIOVENOUS FISTULA. THE 8.0 X 60/135 (4F) STERLING BALLOON CATHETER WAS USED DURING THE TREATMENT PROCEDURE WHEN IT WAS REPORTED THAT THE BALLOON HAD TROUBLE INFLATING (NUMEROUS INFLATIONS) AND ALSO WOULD NOT DEFLATE (CONTRAST WAS NOT COMING OUT OF THE BALLOON). IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER BEING INFLATED 10-12ATMS FOR APPROXIMATELY 30 SECONDS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031806010 14451961

    Patients

    Seq Age Sex Outcome Treatment
    1