BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1843008 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04391
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE PERIPHERAL CUTTING BALLOON WAS RETURNED AND HAD EVIDENCE OF BEING INFLATED. VISUAL EXAMINATION REVEALED THE SHAFT WAS STRETCHED FOR 89MM FROM THE PROXIMAL BOND. THE SHAFT WAS KINKED IN TWO LOCATIONS, 43MM AND 68MM FROM THE PROXIMAL BOND. MICROSCOPIC EXAMINATION IDENTIFIED A 16MM SECTION OF ONE BLADE AND PAD DETACHED AT THE PROXIMAL END OF THE BALLOON. THE BALLOON MATERIAL WAS DAMAGED WHERE THE BLADE WAS DETACHED. THE PROXIMAL TIP OF THE PAD REMAINED BONDED TO THE BALLOON SURFACE. THE OTHER THREE BLADES WERE FULLY BONDED TO THE BALLOON SURFACE WITH NO DAMAGE NOTED. NO FURTHER DAMAGE WAS NOTED ON THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A HEMODIALYSIS PROCEDURE, A BLADE PARTIALLY DETACHED. VASCULAR ACCESS WAS OBTAINED IN THE UPPER RIGHT ARM. THE 90% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS VEIN SHUNT. THE PHYSICIAN ADVANCED THE 8.0MM X 2.0CM PERIPHERAL CUTTING BALLOON (PCB) CATHETER AND DILATED THE LESION. THE BALLOON WAS FULLY DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. NO RESISTANCE WAS NOTED. AFTER REMOVAL OF THE DEVICE THE PHYSICIAN NOTED ONE OF THE BLADE PADS AND BLADE WERE PARTIALLY SEPARATED FROM THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A HEMODIALYSIS PROCEDURE, A BLADE PARTIALLY DETACHED. VASCULAR ACCESS WAS OBTAINED IN THE UPPER RIGHT ARM. THE 90% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS VEIN SHUNT. THE PHYSICIAN ADVANCED THE 8.0MM X 2.0CM PERIPHERAL CUTTING BALLOON (PCB) CATHETER AND DILATED THE LESION. THE BALLOON WAS FULLY DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. NO RESISTANCE WAS NOTED. AFTER REMOVAL OF THE DEVICE THE PHYSICIAN NOTED ONE OF THE BLADE PADS AND BLADE WERE PARTIALLY SEPARATED FROM THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP90820B0 EK5606

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR