BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2071649 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01610
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE STERLING BALLOON CATHETER WAS RETURNED WITH NO ORIGINAL PACKAGING. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED. THE INNER DIAMETER OF THE TIP AND WIRE EXIT NOTCH WERE MEASURED AND MET SPECIFICATIONS. A GUIDE WIRE WAS ADVANCED ALL THE WAY THROUGH THE WIRE LUMEN WITH NO RESISTANCE. 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

    SAME CASE AS MFR: 2134265-2011-01609. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TOTALLY OCCLUDED LESION WAS LOCATED IN A NON TORTUOUS AND HEAVILY CALCIFIED TIBIAL ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.0MM X 40MM STERLING ES BALLOON CATHETER ON TO THE 300CM JOURNEY GUIDE WIRE HOWEVER; NEAR THE END, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE BALLOON CATHETER AND GUIDE WIRE WERE REMOVED FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON CATHETER AND A DIFFERENT GUIDE WIRE. 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 ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 0013975834

    Patients

    Seq Age Sex Outcome Treatment
    1 300CM JOURNEY GUIDE WIRE