BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 1993411 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00320
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 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 DEVICE SHOWED EVIDENCE OF BEING INFLATED. THE SHEATH WAS RETURNED WITH THE DEVICE. THE SHEATH WAS SPLIT 9MM IN LENGTH FROM THE DISTAL END. THE BALLOON APPEARED WINGED, AS IF IT HAD NOT BEEN DEFLATED PROPERLY. MICROSCOPIC EXAMINATION OF THE BALLOON IDENTIFIED A 5MM SEGMENT ON THE CENTER OF A BLADE WAS DETACHED FROM THE BALLOON. THE BLADE SEGMENT WAS NOT RETURNED WITH THE DEVICE. THE PAD REMAINED BONDED TO THE BALLOON SURFACE. THE DEVICE WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WITHOUT ISSUE. NO FURTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS USER/ USE ERROR. THE DFU STATES: IF RESISTANCE IS ENCOUNTERED WHEN REMOVING THE CATHETER THROUGH AN INTRODUCER SHEATH OR A GUIDE WIRE THROUGH THE CATHETER, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDE WIRE, CATHETER, INTRODUCER SHEATH, OR VESSEL. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, REMOVAL DIFFICULTY AND A BLADE DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH A RADIAL VEIN. THE 90% STENOSED LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS 'SHUNT VEIN.' DURING WITHDRAWAL OF THE 4.0MM X 1.5CM FLEXTOME BALLOON CATHETER THROUGH A NON-BSC INTRODUCER SHEATH, THE BALLOON BECAME STUCK IN THE PROXIMAL PART OF THE SHEATH AND THE SHEATH WAS TORN. ONCE THE DEVICE WAS REMOVED OUTSIDE OF THE PATIENT, IT WAS NOTED THAT A BLADE WAS DETACHED AND WAS STUCK IN THE SHEATH. ANGIOGRAPHY WAS PERFORMED TO ENSURE NO VESSEL DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, REMOVAL DIFFICULTY AND A BLADE DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH A RADIAL VEIN. THE 90% STENOSED LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS 'SHUNT VEIN.' DURING WITHDRAWAL OF THE 4.0MM X 1.5CM FLEXTOME BALLOON CATHETER THROUGH A NON-BSC INTRODUCER SHEATH, THE BALLOON BECAME STUCK IN THE PROXIMAL PART OF THE SHEATH AND THE SHEATH WAS TORN. ONCE THE DEVICE WAS REMOVED OUTSIDE OF THE PATIENT, IT WAS NOTED THAT A BLADE WAS DETACHED AND WAS STUCK IN THE SHEATH. ANGIOGRAPHY WAS PERFORMED TO ENSURE NO VESSEL DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS 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 13824829

    Patients

    Seq Age Sex Outcome Treatment
    1 6F TERUMO INTRODUCER SHEATH