BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3961951 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04284
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A STERLING BALLOON CATHETER WITH A STERLING PRODUCT POUCH AND STOPCOCK. THE STOPCOCK WAS ATTACHED TO THE HUB; AS RECEIVED. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WERE MULTIPLE KINKS THROUGHOUT THE SHAFT. MICROSCOPIC EXAMINATION OF THE BALLOON AND SHAFT REVEALED A 17MM LONGITUDINAL TEAR FROM THE MID-SECTION TO THE DISTAL END OF THE BALLOON. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OR REPORTED EVENT. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT 'BALLOON WAS NOT CORRECTLY BUILT FOR USE' OCCURRED. A 4.0MMX20MMX80CM (4F) STERLING¿ CATHETER BALLOON WAS SELECTED TO DILATE THE LESION BUT IT WAS NOTED THAT THE 'BALLOON WAS NOT CORRECTLY BUILT FOR USE'. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438158 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032402080 14273484

    Patients

    Seq Age Sex Outcome Treatment
    1