BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1771709 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03227
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 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

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED DRIED BLOOD AND CONTRAST PRESENT IN THE SHAFT AND BALLOON. THE BALLOON WAS RECEIVED IN A DEFLATED STATE. THE BALLOON WAS INSPECTED UNDER MAGNIFICATION AND A PINHOLE WAS CONFIRMED IN THE BALLOON WALL LOCATED 30MM FROM THE TIP. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE PINHOLE DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE PINHOLE. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE BURST. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE DEVICE REVEALED DAMAGE TO THE DISTAL TIP. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TIP 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY AND AN IPSILATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT POSTERIOR TIBIAL ARTERY. A 4F 60CM SHEATH WAS INSERTED. TWO NON-BSC GUIDE WIRES CROSSED THE LESION. A 2.0X100MM NON-BSC BALLOON CATHETER WAS ADVANCED BUT DID NOT CROSS THE LESION. A STERLING ES OTW 2MM X 40MM X 144CM WAS ADVANCED ACROSS THE LESION. THE BALLOON WAS INFLATED ONCE TO 6 ATMS AND ONCE TO 8 ATMS. ON THE 3RD INFLATION, THE BALLOON RUPTURED AT 12ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS 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 H74939134204010 12049650

    Patients

    Seq Age Sex Outcome Treatment
    1 TREASURE XS GUIDE WIRE| 4F 60CM SHEATH| EXTREME PV GUIDE WIRE