BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON®

    MDR report key: 2993160 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01302
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS RELATED TO USER ERROR AS THE DFU STATES THE MINIMUM RECOMMENDED SHEATH FOR THIS SIZE DEVICE IS 7F (2.33 MM) IT WAS REPORTED THAT A 6F SHEATH WAS USED DURING THIS PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SUPERFICIAL FEMORAL ARTERY TREATMENT PROCEDURE, A LIFTED BLADE WAS NOTED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7.00 MM/2.0 CM/135 CM PERIPHERAL CUTTING BALLOON WAS BEING USED WITH AN UNKNOWN MANUFACTURER'S 6F SHEATH. THE CUTTING BALLOON WAS INFLATED TO 6 ATM THEN DEFLATED AND INFLATED TO 10 ATM. THE CUTTING BALLOON WAS REMOVED AND THE PHYSICIAN EXAMINED THE DISTAL PORTION OF THE DEVICE PRIOR TO PUTTING THE DEVICE BACK ONTO AN UNKNOWN MANUFACTURER'S GUIDE WIRE AND NOTED A LIFTED BLADE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 7.0 MM X 2.0 CM CUTTING BALLOON THAT WAS INFLATED FOR ABOUT 2 MINUTES AND 15 SECONDS. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96757 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB70201350 15668384

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR