BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 1983819 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00441
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION IDENTIFIED SOLIDIFIED BLOOD IN THE BALLOON AND INFLATION LUMEN. THE CATHETER WAS RETURNED WITH A SEVERELY DAMAGED STENT ATTACHED TO THE DISTAL SHAFT. MICROSCOPIC EXAMINATION IDENTIFIED ONE PROXIMAL BLADE WAS DETACHED FROM THE BALLOON. THE MIDSHAFT WAS ELONGATED AND KINKED IN SEVERAL PLACES. THE HYPOTUBE SHAFT WAS SEVERELY KINKED ALONG THE ENTIRE LENGTH. THE LENGTH OF THE TIP TO THE RX PORT WAS APPROXIMATELY 24.3CM AND WAS WITHIN SPECIFICATIONS. THE LENGTH OF THE TIP TO THE DISTAL HYPOTUBE MARKER WAS 110CM AS THIS DOES NOT MEET SPECIFICATIONS. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE HOWEVER A LEAK WAS NOTED. FURTHER EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A PINHOLE AT THE PROXIMAL END OF THE BALLOON WHERE THE MISSING BLADE WAS INITIALLY. 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 PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN TWO RESTENOSED NON-BSC STENTS LOCATED IN AN UNSPECIFIED VESSEL. THE 3.0MM X 10MM FLEXTOME CUTTING BALLOON CATHETER BECAME STUCK ON ONE OF THE STENTS. THE PHYSICIAN "HAD TO USE A LITTLE FORCE TO REMOVE THE CUTTING BALLOON." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN TWO RESTENOSED NON-BSC STENTS LOCATED IN AN UNSPECIFIED VESSEL. THE 3.0MM X 10MM FLEXTOME CUTTING BALLOON CATHETER BECAME STUCK ON ONE OF THE STENTS. THE PHYSICIAN "HAD TO USE A LITTLE FORCE TO REMOVE THE CUTTING BALLOON." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM3300100 EK5261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR