BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2101113 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-02254
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED PRODUCT REVEALED A BLOOD-LIKE SUBSTANCE IN THE INFLATION LUMEN AND BALLOON. THERE WERE TWO HOLES IN THE SHAFT 14.5 AND 14CM FROM THE TIP. WHEN POSITIVE PRESSURE WAS APPLIED WITH THE INFLATION DEVICE, A STREAM OF WATER EMITTED FROM THE HOLE IN THE SHAFT 14.5 CM FROM THE TIP. THERE WERE SCRATCHES NEAR THE HOLES. INSPECTION OF THE SHAFT PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE DAMAGE TO THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A LEAK WAS OBSERVED IN THE BALLOON CATHETER. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS RADIAL VEIN. THE 5.0X20MM STERLING BALLOON CATHETER WAS ADVANCED INTO THE PATIENT WITH NO RESISTANCE NOTED. PRIOR TO INFLATION ATTEMPTS, BLOOD FLOWED INTO THE INFLATION LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED TWO HOLES IN THE CATHETER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032502080 12669335

    Patients

    Seq Age Sex Outcome Treatment
    1 4FR TERUMO GUIDING INTRODUCER| TERUMO GT GUIDE WIRE