BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3242338 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04997
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMED A COMPLETE BALLOON DETACH. THE BALLOON HAD DETACHED AT THE PROXIMAL AND DISTAL BALLOON BONDS. THE BALLOON WAS NOT RETURNED. NO OTHER DAMAGE WAS NOTED TO THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF AN ARTERIOVENOUS FISTULA ANGIOPLASTY PROCEDURE, A TIP OF THE BALLOON CATHETER CAME OFF. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.00MM X 1.5CM X 140CM SPCB FLEXTOME MONORAIL CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, WHEN THE BALLOON PROTECTOR WAS PULLED, THE ENTIRE TIP OF THE DEVICE CAME OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF AN ARTERIOVENOUS FISTULA ANGIOPLASTY PROCEDURE, A TIP OF THE BALLOON CATHETER CAME OFF. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.00 MM X 1.5 CM X 140 CM SPCB FLEXTOME MONORAIL CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, WHEN THE BALLOON PROTECTOR WAS PULLED, THE ENTIRE TIP OF THE DEVICE CAME OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF AN ARTERIOVENOUS FISTULA ANGIOPLASTY PROCEDURE, A TIP OF THE BALLOON CATHETER CAME OFF. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.00MM X 1.5CM X 140CM SPCB FLEXTOME MONORAIL CUTTING BALLOON WAS SELECTED TO TREAT THE TARGET LESION. DURING UNPACKING, WHEN THE BALLOON PROTECTOR WAS PULLED, THE ENTIRE TIP OF THE DEVICE CAME OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343204 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBM4015140F0 0015756145

    Patients

    Seq Age Sex Outcome Treatment
    1