BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 2002639 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00314
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 31, 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

    DEVICE EVALUATED BY MFR.: VISUAL EXAMINATION OF THE FLEXTOME CUTTING BALLOON FOUND THE RETURNED BALLOON HAD EVIDENCE OF BEING INFLATED WITH BLOOD PRESENT IN THE BALLOON. NO DAMAGE WAS NOTED TO THE DISTAL TIP OF THE DEVICE. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE (RBP) HOWEVER, A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED A PINHOLE LEAK 5MM DISTAL TO THE PROXIMAL END OF THE BLADES. ONE BLADE WAS BENT 3MM PROXIMAL TO THE DISTAL END AND ALSO BENT IN THE CENTRE OF THE BLADE. A SECOND BLADE WAS PARTIALLY LIFTED 5MM-7.5MM FROM THE PROXIMAL END OF THE BLADE. NO PART OF THE DEVICE, BALLOON, OR BLADES MISSING. 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)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6)-2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, DIFFICULTY CROSSING OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE LEFT BRACHIAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT COMMON FEMORAL ARTERY (CFA). FOR PRE DILATION, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 4.0MM X 1.5CM FLEXTOME CUTTING BALLOON HOWEVER, COULD NOT CROSS THE LESION. THE 2.0MM X 20MM STERLING ES BALLOON CATHETER AND THEN A 3.0MM X 20MM STERLING ES BALLOON CATHETER WERE USED SUCCESSFULLY. THE FLEXTOME WAS ADVANCED AGAIN AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, ANALYSIS OF THE 4.0MM X 1.5CM FLEXTOME CUTTING BALLOON REVEALED A LIFTED BLADE.

    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 13586195

    Patients

    Seq Age Sex Outcome Treatment
    1 2.00 X 20 STERLING ES OTW BALLOON CATHETER| TRANSEND ES300 GUIDE WIRE| TERUMO 6F DESTINATION 90CM INTRODUCER SHEATH