BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

    MDR report key: 6792889 · Received August 14, 2017

    Report

    Report Number
    1820334-2017-02499
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    August 11, 2017
    Report Date
    November 15, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002308524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER WAS RETURNED FOR INVESTIGATION. NO DAMAGE WAS NOTED TO THE CATHETER OR HUB; HOWEVER, THE DISTAL END OF THE BALLOON IS MISSING. THE PROXIMAL MARKER BAND IS PRESENT. THE DISTAL MARKER BAND IS NOT PRESENT. THE SEPARATED BALLOON EDGE IS JAGGED AND AT A 65 DEGREE ANGLE. BOTH THE MEASUREMENTS FOR THE CATHETER LENGTH AND BALLOON LENGTH WERE OUT OF TOLERANCE. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO DETERMINE IF THE FAILURE OF THE DEVICE WAS ATTRIBUTED TO DEVICE HANDLING, USER TECHNIQUE, AND/OR PATIENT ANATOMY. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS PROVIDED, THIS INVESTIGATION WILL BE REOPENED AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K)# - K130293. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING AN AORTIC ILIAC INTERVENTION INVOLVING A (B)(6) YEAR OLD MALE PATIENT, THE ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER WAS REMOVED AND A PIECE SNAPPED OFF. NO PIECES OF THE DEVICE REMAINED INSIDE THE PATIENT. NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573317 ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 10827002308524

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR