BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1961462 · Received January 14, 2011

    Report

    Report Number
    2134265-2010-05897
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 24, 2010
    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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS IN A DEFLATED STATE WITH A STOPCOCK. DRIED BLOOD AND CONTRAST WERE VISIBLE IN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS PREPPED ACCORDING TO THE DFU, AND A NEW INFLATION DEVICE FILLED WITH WATER WAS CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE, A STREAM OF WATER EMITTED FROM A HOLE IN THE BALLOON 10MM FROM THE TIP. THE BALLOON WAS BUNCHED UP AT THE DISTAL END OF THE BALLOON AND THE TIP WAS DAMAGED. 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 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE PHYSICIAN WAS PRE-DILATING A 95% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY WITH THIS 2MM X 40MM X 145CM STERLING ES BALLOON CATHETER. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6ATMS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.50X40MM STERLING ES BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE PHYSICIAN WAS PRE-DILATING A 95% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY WITH THIS 2MM X 40MM X 145CM STERLING ES BALLOON CATHETER. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6ATMS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.50X40MM STERLING ES BALLOON CATHETER. 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 H74939135204010 13568808

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO 5F LONG SHEATH| INFLATION DEVICE: EVEREST| GW: CRUISE, TREASURE XS