BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON®

    MDR report key: 3203110 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04648
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMED A COMPLETE BALLOON DETACH FROM THE PROXIMAL AND DISTAL BALLOON BONDS. THE BALLOON PROTECTOR WAS RETURNED SEPARATE TO THE BALLOON. NO KINKS OR DAMAGE WERE NOTED ALONG THE REMAINING SHAFT OF THE DEVICE. A MICROSCOPIC EXAMINATION OF THE TIP, REMAINING SECTIONS OF THE BALLOON, AND BLADES FOUND NO ISSUES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A VASCULAR PROCEDURE, BALLOON DETACHMENT OCCURRED. DURING PREPARATION, REMOVAL OF THE BALLOON PROTECTOR WAS ATTEMPTED; HOWEVER, IT WOULD NOT BE REMOVED. WHEN THE BALLOON PROTECTOR WAS REMOVED WITH FORCE, THE BALLOON SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT¿S CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A VASCULAR PROCEDURE, BALLOON DETACHMENT OCCURRED. DURING PREPARATION, REMOVAL OF THE BALLOON PROTECTOR WAS ATTEMPTED; HOWEVER, IT WOULD NOT BE REMOVED. WHEN THE BALLOON PROTECTOR WAS REMOVED WITH FORCE, THE BALLOON SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT¿S CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A VASCULAR PROCEDURE, BALLOON DETACHMENT OCCURRED. DURING PREPARATION, REMOVAL OF THE BALLOON PROTECTOR WAS ATTEMPTED; HOWEVER, IT WOULD NOT BE REMOVED. WHEN THE BALLOON PROTECTOR WAS REMOVED WITH FORCE, THE BALLOON SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302220 SMALL PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001PCBM4015140F0 0015756145

    Patients

    Seq Age Sex Outcome Treatment
    1