BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME? CUTTING BALLOON?

    MDR report key: 3050753 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02109
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A HYPOTUBE KINK APPROXIMATELY 45.5CM FROM THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM DURING USE/HANDLING. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS CONFIRMED A PINHOLE IN THE DISTAL BALLOON BODY. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A VESSEL PERFORATION OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. USING A MACH 1 GUIDE CATHETER, THE PHYSICIAN ADVANCED A 10X2.50MM FLEXTOME CUTTING BALLOON CATHETER TO THE TARGET LESION. UPON THE SECOND INFLATION AT 6ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND A PERFORATION WAS NOTED. THE PROCEDURE WAS COMPLETED BY INFLATING A 2.5MM NON-BSC BALLOON CATHETER TO TREAT THE PERFORATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A VESSEL PERFORATION OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. USING A MACH 1 GUIDE CATHETER, THE PHYSICIAN ADVANCED A 10X2.50MM FLEXTOME CUTTING BALLOON CATHETER TO THE TARGET LESION. UPON THE SECOND INFLATION AT 6ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND A PERFORATION WAS NOTED. THE PROCEDURE WAS COMPLETED BY INFLATING A 2.5MM NON-BSC BALLOON CATHETER TO TREAT THE PERFORATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149190 FLEXTOME? CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4250100 0015760428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention