BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLO BALLOON GUIDE CATHETER 8F

    MDR report key: 7125790 · Received December 18, 2017

    Report

    Report Number
    2029214-2017-01362
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Report Date
    March 9, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K120781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON GUIDE CATHETER WAS RETURNED FOR ANALYSIS. NO ISSUES WERE FOUND WITH THE MAIN LUMEN OR BALLOON LUMEN HUBS. THE BALLOON INFLATION PORT WAS FOUND TO BE INTACT. THE BALLOON GUIDE CATHETER BODY WAS FOUND TO BE FLATTENED NEAR THE DISTAL TIP. THE BALLOON TIP WAS FOUND TO BE FLATTENED; HOWEVER, UPON VISUAL EXAMINATION NO DEFECTS WERE FOUND WITH THE BALLOON. THE BALLOON GUIDE CATHETER MAIN LUMEN WAS FLUSHED, AND WATER EXITED FROM THE DISTAL TIP. THE BALLOON WAS SUCCESSFULLY INFLATED TO NOMINAL SPECIFICATION AND HELD INFLATION FOR FIVE MINUTES UNTIL THE TEST WAS STOPPED. NO HOLES OR LEAKS WERE DETECTED. THE BALLOON WAS THEN SUCCESSFULLY DEFLATED WITHOUT ISSUE. NO OTHER ANOMALIES WERE OBSERVED. THE DEVICE WAS SENT TO FUJI AND THEY REPORTED THAT: "TO CHECK THE CONDUCTION STATE FOR THE RETURNED PRODUCT, WE INFLATED AND DEFLATED THE BALLOON WITH 1ML WATER. THE BALLOON WAS SUCCESSFULLY INFLATED AND DEFLATED WITHOUT FRICTION. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿NO/SLOW DEFLATION DURING SET UP¿ COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. PER THE FUJI INVESTIGATION REPORT, ¿WE DO CHECK ALL BALLOON BY AIR INFLATION AND ONLY ACCEPTED PRODUCTS ARE SHIPPED. WE CONCLUDED THAT THE RETURNED DEVICE IS NORMAL PRODUCT AS WE COULDN'T CONFIRM THE PHENOMENON AT OUR INVESTIGATION. PLEASE KEEP TESTING THE BALLOON BEFORE USE, AND IF ANY ABNORMALITY WAS FOUND PLEASE DO NOT USE IT.¿ DURING THE DEVICE ANALYSIS, THE CELLO BALLOON GUIDE CATHETER BODY WAS FOUND TO BE FLATTENED. IT IS POSSIBLE THAT THE CELLO BECAME FLATTENED DURING SHIPPING BACK TO MEDTRONIC FOR EVALUATION AS THE CUSTOMER REPORTED NO DAMAGES TO THE CELLO AT THE TIME OF THE EVENT. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. IN ADDITION, ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THEREFORE, MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. AS NOTED IN THE CELLO IFU (INSTRUCTIONS FOR USE): ¿DEFLATE THE BALLOON BY TURNING STOPCOCK OFF TOWARDS THE 1 ML SYRINGE AND ASPIRATING WITH THE 20 ML SYRINGE.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE CELLO BALLOON GUIDE CATHETER WAS RETURNED FOR ANALYSIS AND DECONTAMINATED. THE TOTAL LENGTH AND USABLE LENGTHS OF THE CELLO BALLOON GUIDE CATHETER WERE MEASURED. NO ISSUES WERE FOUND WITH THE MAIN LUMEN OR BALLOON LUMEN HUBS. THE BALLOON INFLATION PORT WAS FOUND TO BE INTACT. THE CELLO BALLOON GUIDE CATHETER BODY WAS FOUND TO BE FLATTENED NEAR THE DISTAL TIP. THE BALLOON TIP WAS FOUND TO BE FLATTENED; HOWEVER, UPON VISUAL EXAMINATION NO DEFECTS WERE FOUND WITH THE BALLOON. THE CELLO BALLOON GUIDE CATHETER MAIN LUMEN WAS FLUSHED, AND WATER EXITED FROM THE DISTAL TIP. THE BALLOON WAS SUCCESSFULLY INFLATED TO NOMINAL SPECIFICATION AND HELD INFLATION FOR FIVE MINUTES UNTIL THE TEST WAS STOPPED. NO HOLES OR LEAKS WERE DETECTED. THE BALLOON WAS THEN SUCCESSFULLY DEFLATED WITHOUT ISSUES. NO OTHER ANOMALIES WERE OBSERVED. THE DEVICE WAS SENT OUT FOR FURTHER ANALYSIS. ONCE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE ANALYSIS HAS NOT BEEN COMPLETED. ONCE THE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON GUIDE CATHETER COULD NOT BE DEFLATED DURING PREPARATION AND WAS REPLACED WITH ANOTHER BALLOON GUIDE CATHETER WITH SAME NAME. THE BALLOON GUIDE CATHETER WAS ONLY INFLATED ONCE BEFORE IT COULD NOT DEFLATE. THERE WERE NO ISSUES WITH INFLATING THE BALLOON. THE CELLO COULD NOT BE DEFLATED USING A SYRINGE DURING PREPARATION. THE DEVICE WAS PREPARED AS INDICATED BY THE INSTRUCTIONS FOR USE (IFU). THE BALLOON GUIDE CATHETER WAS FLUSHED PER THE IFU. THERE WERE NO KINKS, BENDS OR DAMAGES NOTICED ON THE CELLO. THE CONTRAST RATIO USED WAS 50/50. THE SIZE OF THE SYRINGE USED FOR INFLATION WAS 1ML AND THE SIZE OF SYRINGE USED FOR DEFLATION WAS 20CC. THE DETACHABLE INFLATION PORT WAS USED AND IT WILL BE RETURNED ALONG WITH THE CELLO FOR INVESTIGATION. THERE WERE NO ANCILLARY DEVICES USED. THE PRODUCT WILL BE RETURNED BUT WORKING ON GETTING TRACKING NUMBER. THE EXACT DATE OF THE EVENT IS UN KNOWN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THE EVENT SINCE THE DEVICE WAS NOT USED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903486 CELLO BALLOON GUIDE CATHETER 8F CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 1610080 5700073

    Patients

    Seq Age Sex Outcome Treatment
    1