BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 1990041 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00279
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    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 MANUFACTURER: MAGNIFIED INSPECTION REVEALED A HOLE IN THE SHAFT 69 CM FROM THE STRAIN RELIEF AND KINKS IN THE BALLOON AND INNER SHAFT LOCATED 8 AND 9.5 CM FROM THE TIP. THERE WAS 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% CHRONIC TOTAL OCCLUSION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT POSTERIOR TIBIAL ARTERY. THE LESION WAS PRE-DILATED WITH A 1.5 X 20MM STERLING ES OVER-THE-WIRE BALLOON CATHETER. POST DILATATION WAS PERFORMED WITH THE 2.0MM X 120 X 150 STERLING SL MONORAIL BALLOON CATHETER. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 3ATMS. 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 SL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939147201210 13743925

    Patients

    Seq Age Sex Outcome Treatment
    1 5FR 55CM MEDIKIT INTRODUCER SHEATH| 1.5 X 20MM STERLING ES| ASTATO XS GUIDE WIRE| CRUISE GUIDE WIRE