BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6446203 · Received March 30, 2017

    Report

    Report Number
    1820334-2017-00603
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 30, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002309644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT AGE UNKNOWN, PATIENT WAS REPORTEDLY IN HIS (B)(6). INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS RETURNED FOR INVESTIGATION. THE DISTAL PORTION OF THE BALLOON IS MISSING. THE BALLOON IS RUPTURED RADIALLY AND THE DISTAL MARKER BAND IS MISSING. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE TO THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    CODE 510(K) #; K130293. THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION/DILATION, WHILE USING AN ADVANCE 18 LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED (CIRCUMFERENTIALLY) WHILE BEING INFLATED. IT WAS REPORTED THAT ALTHOUGH THERE WAS NO ANGULATION, THERE WAS HEAVY CALCIFICATION OF THE VESSEL. AT THE TIME THE BALLOON WAS BEING WITHDRAWN, THERE WAS VERY LITTLE RESISTANCE AND IT WAS NOTED TO BE IN 2 PIECES. THE PATIENT UNDERWENT AN ADDITIONAL ANGIOPLASTY PROCEDURE USING A COOK 6X100 BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228910 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 10827002309644

    Patients

    Seq Age Sex Outcome Treatment
    1