BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2170438 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02748
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STERLING ES MONORAIL (MR) DEVICE WAS RECEIVED WITH BLOOD AND CONTRAST IN THE BALLOON AND WIRE LUMEN. THERE WAS PINHOLE IN THE BALLOON WALL MATERIAL. THE PINHOLE WAS LOCATED ON THE DISTAL EDGE OF THE MARKERBAND. THERE WAS ALSO DISTAL TIP DAMAGE. MICROSCOPIC INSPECTION OF THE BALLOON MATERIAL AND THE REMAINDER OF THE DEVICE REVEALED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGED BALLOON. 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

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS RIGHT PERONEAL ARTERY. THE 1.5 X 20MM X 135CM STERLING ES MONORAIL BALLOON CATHETER WAS INFLATED TO 12 ATMS UPON ITS FIRST INFLATION, AND THEN RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS RIGHT PERONEAL ARTERY. THE 1.5 X 20MM X 135CM STERLING ES MONORAIL BALLOON CATHETER WAS INFLATED TO 12 ATMS UPON ITS FIRST INFLATION, AND THEN RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 H74939135152010 14175750

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC INFLATION DEVICE| SJM TREASURE GUIDE WIRE| 4FR INTRODUCER