BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2101123 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-01874
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: THE STERLING BALLOON CATHETER WAS RECEIVED WITH BLOOD LIKE SUBSTANCE IN THE BALLOON. THERE WAS A PINHOLE IN THE BALLOON 4 MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. 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

    SAME CASE AS 2134265-2011-01859. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE BALLOON RUPTURES OCCURRED. THE 90% STENOSED DE NOVO LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 60/135 STERLING MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WHEN THE BALLOON RUPTURED AT 8 ATM ON THE INITIAL INFLATION. THE DEVICE WAS EXCHANGED FOR ANOTHER 6.0 X 40MM STERLING BALLOON CATHETER TO COMPLETE PRE-DILATION. THEN AN 8.0 X 80MM NON-BSC STENT WAS IMPLANTED. THE 7.0 X 40/135 STERLING MONORAIL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION WHEN THE BALLOON RUPTURED AT 6 ATM ON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 7.0 X 60MM STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-01859. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE BALLOON RUPTURES OCCURRED. THE 90% STENOSED DE NOVO LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 60/135 STERLING MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WHEN THE BALLOON RUPTURED AT 8 ATM ON THE INITIAL INFLATION. THE DEVICE WAS EXCHANGED FOR ANOTHER 6.0 X 40MM STERLING BALLOON CATHETER TO COMPLETE PRE-DILATION. THEN AN 8.0 X 80MM NON-BSC STENT WAS IMPLANTED. THE 7.0 X 40/135 STERLING MONORAIL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION WHEN THE BALLOON RUPTURED AT 6 ATM ON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 7.0 X 60MM STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031606010 13704915

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATHLESS PV 6F INTRODUCER SHEATH| THRUWAY GUIDE WIRE