BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2203042 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03521
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE RETURNED BALLOON SHOWED EVIDENCE OF BEING INFLATED WITH CONGEALED CONTRAST MEDIA IN THE SHAFT. A CLEAR INFLATION/DEFLATION PATH WAS NOTED AT THE PROXIMAL BOND. NO DAMAGE WAS NOTED TO THE PROXIMAL BOND. A SEVERE TWIST WAS NOTED IN THE SHAFT AT THE GUIDEWIRE EXIT PORT. THE SHAFT WAS ALSO SEVERELY TWISTED 24MM DISTAL TO THE MIDSHAFT TO HYPOTUBE BOND. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE (RBP) BUT IT COULD NOT BE INFLATED DUE TO THE CONGEALED CONTRAST MEDIA. THE DEVICE WAS SOAKED IN WARM WATER AND THE DEVICE WAS INFLATED SUCCESSFULLY AND DEFLATED SUCCESSFULLY WITHIN SPECIFICATION. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. 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 PERIPHERAL TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE 85% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS BRACHIUM SHUNT. THE 4.0MM X 1.5CM X 140CM OUS SPCB FLEXTOME MONORAIL BALLOON CATHETER WAS INFLATED FOUR TIMES AT 6 ATMS WITHOUT INCIDENT. DURING THE FIFTH INFLATION AT 6 ATMS, THERE WAS DIFFICULTY DEFLATING THE DEVICE. THE BALLOON CATHETER WAS REMOVED WITH THE BALLOON NOT COMPLETELY DEFLATED. WHEN REMOVING THE DEVICE, RESISTANCE WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, DEFLATION DIFFICULTIES OCCURRED. THE 85% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS BRACHIUM SHUNT. THE 4.0MM X 1.5CM X 140CM OUS SPCB FLEXTOME MONORAIL BALLOON CATHETER WAS INFLATED FOUR TIMES AT 6 ATMS WITHOUT INCIDENT. DURING THE FIFTH INFLATION AT 6 ATMS, THERE WAS DIFFICULTY DEFLATING THE DEVICE. THE BALLOON CATHETER WAS REMOVED WITH THE BALLOON NOT COMPLETELY DEFLATED. WHEN REMOVING THE DEVICE, RESISTANCE WAS ENCOUNTERED. 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 SMALL PERIPHERAL CUTTING BALLOON¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 14330246

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC INFLATION DEVICE| 6FR INTRODUCER SHEATH