BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2CM PERIPHERAL CUTTING BALLOON¿

    MDR report key: 2880127 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-07977
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION FOUND NO TEARS VISIBLE IN THE BALLOON MATERIAL. HOWEVER, DURING AN ATTEMPT TO INFLATE THE BALLOON A PINHOLE LEAK WAS IDENTIFIED IN THE MID BODY OF THE BALLOON. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND BLADES IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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 AN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS VENOUS ANASTOMATIC SITE. THE PHYSICIAN ADVANCED A 5.0MM X 2.0CM X 50CM PCB CUTTING BALLOON TO THE LESION AND WAS INFLATED TO 6ATM. THE CUTTING BALLOON RUPTURED AT 7ATM DURING THE SECOND INFLATION. A VESSEL RUPTURE WAS NOTED; HOWEVER, IT IS UNCLEAR WHAT CAUSED THE RUPTURE. THE PHYSICIAN PERFORMED LIGATION OF THE VESSEL. THE PROCEDURE WAS CONSIDERED COMPLETED WITH THIS DEVICE. THE PATIENT WAS SENT FOR SURGERY AT A LATER DATE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS VENOUS ANASTOMATIC SITE. THE PHYSICIAN ADVANCED A 5.0MM X 2.0CM X 50CM PCB CUTTING BALLOON TO THE LESION AND WAS INFLATED TO 6ATM. THE CUTTING BALLOON RUPTURED AT 7ATM DURING THE SECOND INFLATION. A VESSEL RUPTURE WAS NOTED; HOWEVER, IT IS UNCLEAR WHAT CAUSED THE RUPTURE. THE PHYSICIAN PERFORMED LIGATION OF THE VESSEL. THE PROCEDURE WAS CONSIDERED COMPLETED WITH THIS DEVICE. THE PATIENT WAS SENT FOR SURGERY AT A LATER DATE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP50520B0 14329838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention