BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1832452 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04259
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE RETURNED BALLOON HAD EVIDENCE OF BEING INFLATED. THERE WAS NO DAMAGE TO THE SHAFT. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND INFLATED TO ITS RATED BURST PRESSURE (RBP) WITHOUT ISSUE. WHEN THE BALLOON WAS INFLATED, IT WAS NOTED THAT THE DISTAL END OF THE BALLOON WAS SLIGHTLY CURVED. THE TWO BLADES AT THE INNER ANGLE OF THE BALLOON CURVE WERE BENT ALONG THE DISTAL HALF OF THE BALLOON. THE TWO BLADES ON THE OUTER ANGLE OF THE BALLOON CURVE HAD PARTIALLY DETACHED. ONE BLADE HAD LIFTED 13MM FROM THE PROXIMAL END OF THE BALLOON. THE SECOND BLADE HAD LIFTED 9MM FROM THE DISTAL END OF THE BALLOON. NO OTHER 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY TREATMENT PROCEDURE, THE ARTHROTOMIES WERE BENT. THE 40% STENOSED FIBROUS LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA OF THE ARM. THE 6.0MM/2.0CM/ 90CM OVER-THE-WIRE PERIPHERAL CUTTING BALLOON (PCB) WAS ADVANCED THROUGH AN 8FR SHEATH. THE BALLOON WAS USED TO DILATE THE LESION SUCCESSFULLY. THE NUMBER OF INFLATIONS IS UNKNOWN. UPON WITHDRAWAL OF THE BALLOON CATHETER, THE PHYSICIAN NOTICED THAT THE ARTHROTOMIES BECAME BENT AS THE BALLOON WAS COMING THROUGH THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. RETURNED PRODUCT ANALYSIS FOUND THE BLADES TO BE DETACHED AND LIFTED OFF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB6020900 13456429

    Patients

    Seq Age Sex Outcome Treatment
    1 8FR SHEATH