BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3822469 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02774
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A STERLING CATHETER WITH A BOSTON SCIENTIFIC PCB CATHETER. THERE WAS NO DAMAGE NOTED TO THE PCB CATHETER. ANALYSIS OF THE STERLING CATHETER REVEALED THE FOLLOWING: THERE WAS BLOOD IN THE WIRE LUMEN. MAGNIFIED INSPECTION REVEALED A PINHOLE IN THE BALLOON WALL ALIGNED WITH THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. MICROSCOPIC EXAMINATION REVEALED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% INSTENT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. UPON FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% INSTENT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0MMX40MMX80CM (4F) STERLING BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. UPON FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303718 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604080 16723657

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO| GUIDE WIRE: CHEVALIER| INFLATION DEVICE: EVEREST