BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME? CUTTING BALLOON?

    MDR report key: 3090046 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03192
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 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 MANUFACTURER: THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A FURTHER MICROSCOPIC EXAMINATION IDENTIFIED A PINHOLE OVER THE DISTAL EDGE OF A BLADE. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THE TIP OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. 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 THE PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A PERFORATION OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 10/3.00 FLEXTOME CB MONORAIL CUTTING BALLOON WAS USED TO DILATE THE VESSEL. THE PHYSICIAN INFLATED THE DEVICE AT THE NOMINAL LEVEL HOWEVER THE BALLOON RUPTURED AND PERFORATION OCCURRED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS PERFORMED WITH A NON BSC BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. FOLLOW UP OBSERVATION FOR THE PATIENT HAS BEEN PLANNED. "PHYSICIAN COMMENTED THAT THE SIZE OF DEVICE THEY SELECTED WAS SLIGHTLY BIG FOR THE PATIENT'S VESSEL DIAMETER, AND THE CAUSE OF THIS ISSUE WAS NOT FROM THE DEVICE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A PERFORATION OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 10/3.00 FLEXTOME CB MONORAIL CUTTING BALLOON WAS USED TO DILATE THE VESSEL. THE PHYSICIAN INFLATED THE DEVICE AT THE NOMINAL LEVEL HOWEVER THE BALLOON RUPTURED AND PERFORATION OCCURRED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS PERFORMED WITH A NON BSC BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. FOLLOW UP OBSERVATION FOR THE PATIENT HAS BEEN PLANNED. ¿PHYSICIAN COMMENTED THAT THE SIZE OF DEVICE THEY SELECTED WAS SLIGHTLY BIG FOR THE PATIENT'S VESSEL DIAMETER, AND THE CAUSE OF THIS ISSUE WAS NOT FROM THE DEVICE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192417 FLEXTOME? CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4300100 15644776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention