BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6602576 · Received May 31, 2017

    Report

    Report Number
    1820334-2017-01031
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 3, 2017
    Report Date
    July 18, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, SPECIFICATIONS, QUALITY CONTROL, FUNCTIONAL TESTING AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE 18LP LOW PROFILE BALLOON CATHETER WAS RETURNED FOR EXAMINATION. THREE CRACKS WERE NOTED ON THE BALLOON PORT OF THE HUB. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THE BALLOON WOULD NOT INFLATE DUE TO THE CRACKS IN THE BALLOON PORT. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE PROVIDED INFORMATION AND DEVICE EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K130293. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM PROCEDURE USING AN ADVANCE 18 LOW PROFILE BALLOON CATHETER, THE HUB OF THE CATHETER SEPARATED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382631 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 10827002343365

    Patients

    Seq Age Sex Outcome Treatment
    1