BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING? SL

    MDR report key: 3981279 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04594
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THERE WAS NUMEROUS KINKS THROUGHOUT THE SHAFT OF THE DEVICE. MICROSCOPIC EXAMINATION REVEALED A LONGITUDINAL TEAR 1.5CM FROM THE PROXIMAL BALLOON CONE WITH A CIRCUMFERENTIAL TEAR AT THE END. MAJORITY OF THE BALLOON WAS FOLDED INSIDE OUT AND BACKWARDS OVER THE DISTAL TIP. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BONDS OF THE 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED UNSPECIFIED VESSEL. THE 4.0X150MM 150CM STERLING¿ SL BALLOON WAS ADVANCED AND DURING THE FIRST INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.0X150MM 150CM STERLING¿ SL BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED UNSPECIFIED VESSEL. THE 4.0X150MM 150CM STERLING SL BALLOON WAS ADVANCED AND DURING THE FIRST INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.0X150MM 150CM STERLING SL BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457763 STERLING? SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939148301210 16870095

    Patients

    Seq Age Sex Outcome Treatment
    1