BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A4405, 4F-80CM, SYNTEL RT-EMB

    MDR report key: 5824063 · Received July 26, 2016

    Report

    Report Number
    2027111-2016-00538
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 29, 2016
    Report Date
    May 10, 2017
    Manufacturer
    AMR
    Product Code
    DXE
    UDI-DI
    00607915110840
    PMA / PMN Number
    K901627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. A VISUAL INSPECTION WAS PERFORMED USING A PHOTO WAS PROVIDED BY THE COMPLAINANT. BASED ON THE IMAGE PROVIDED, ENGINEERING OBSERVED THAT THE TIP (BALLOON, PROXIMAL AND DISTAL WINDINGS) HAD SEPARATED FROM THE CATHETER. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    FEMORAL CUT DOWN WITH THROMBECTOMY. POSSIBLE STENT PLACEMENT REPORT FROM CUSTOMER: "CATHETER WENT THROUGH GROIN FOR ACCESS TO THE THROMBUS. TIP OF BALLOON BROKE OFF WHEN MOVING THE CATHETER. BALLOON TIP BROKE OFF INSIDE OF THE PATIENT. THE BALLOON IS NOT ON THE DEVICE. THEY WERE NOT ABLE TO RETRIEVE IT." TYPE OF INTERVENTION: "DID NOT OPEN A SECOND UNIT." PATIENT STATUS: "PATIENT IS IN RECOVERY."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RCVD AUGUST 4TH: THEY WERE TRYING TO REMOVE A CLOT & WHEN THEY PULLED BACK, THE BALLOON WAS NO LONG ON THE DISTAL END OF THE CATHETER. BALLOON SHEARED OFF (ENDED UP LOOKING LIKE AN IRRIGATION CATHETER). THEY ENDED UP OPENING THE SAME CATALOG # (A4405) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE BALLOON TIP IS STILL INSIDE THE PATIENT & THE HOSPITAL STAFF CANNOT SEE ANYTHING UNDER FLUOROSCOPY. THE PATIENT HAS NOT COME BACK INTO THE OPERATING ROOM (OR) (TO (B)(6) KNOWLEDGE). RISK MANAGEMENT HAS STRICT ORDERS TO QUARANTINE THE DEVICE USED IN THE EVENT UNTIL FURTHER NOTICE. COLE WILL FOLLOW UP WITH RM TO SEE IF HE CAN SEND THE PRODUCT BACK & IF THE PATIENT HAS COME BACK INTO THE OR FOR ANY FOLLOW UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475883 A4405, 4F-80CM, SYNTEL RT-EMB DXE DXE AMR A4405 1255541 00607915110840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other