BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1950717 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05725
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE REVEALED THERE WAS A BLOOD LIKE SUBSTANCE VISIBLE IN THE GUIDE WIRE LUMEN. THE SHAFT HAD MULTIPLE KINKS 26-34 CM FROM THE TIP. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. THE INNER DIAMETER (ID) OF THE TIP AND WIRE EXIT NOTCH WERE MEASURED AND MET SPECIFICATIONS. THE GUIDE WIRE WAS NOT RETURNED FOR ANALYSIS. A NEW .018" GUIDE WIRE WAS ADVANCED ALL THE WAY THROUGH THE WIRE LUMEN WITH NO RESISTANCE ENCOUNTERED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MEAT ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED TO DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE THE CATHETER BECAME STUCK ON THE GUIDE WIRE. DURING THE PROCEDURE A F/G, STERLING, MR, 3.0 X 40/135 (4F) BALLOON CATHETER BECAME STUCK ON AN UNKNOWN 018 GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE THE CATHETER BECAME STUCK ON THE GUIDE WIRE. DURING THE PROCEDURE A F/G, STERLING, MR, 3.0 X 40/135 (4F) BALLOON CATHETER BECAME STUCK ON AN UNKNOWN 018 GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031304010 13055702

    Patients

    Seq Age Sex Outcome Treatment
    1