BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3842702 · Received June 2, 2014

    Report

    Report Number
    2025587-2014-00341
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY THE HANDLE APPEARED INTACT. THE MICRO KNOB (THUMB WHEEL) APPEARED TO RETRACT AND ADVANCE THE CAPSULE. THE MACRO (CURSOR) MOVED TO FULLY ADVANCE AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. THE DISTAL TIP OF THE CAPSULE SEATED FLUSH AGAINST THE PLUNGER TIP WHEN FULLY ADVANCED. A KINK WAS OBSERVED ON THE PROXIMAL END OF THE CAPSULE. THE PLUNGER TUBE WAS SLIGHTLY BENT. TINY GOUGE MARKS WERE OBSERVED ON THE CATHETER TABS. INVESTIGATION AND DEVICE HISTORY REVIEW IS STILL IN PROCESS, ONCE THE INVESTIGATION AND DEVICE HISTORY REVIEW IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS, THE DELIVERY CATHETER SYSTEM PERFORMED AS INTENDED. A CONCLUSIVE CAUSE WAS UNABLE TO BE DETERMINED. THE LOT HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. ONCE THE ANALYSIS AND INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE DEPLOYMENT OF A 31MM TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) CLICKED MULTIPLE TIMES. THE DCS AND VALVE WERE REMOVED FROM THE PATIENT, AND A SECOND DCS FROM A DIFFERENT LOT WAS USED TO IMPLANT THE VALVE WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE DCS WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT CLICKING WAS NOTED ONCE OR TWICE WHILE LOADING THE VALVE AND APPLYING TRACTION TO THE MACRO-SLIDE REMEDIED THE PROBLEM AFTER LOADING. THE CLICKING BEGIN IMMEDIATELY AT DEPLOYMENT AND CONTINUED THROUGHOUT UNTIL THE MACROSLIDE WAS 3/8 BACK AND THE SHEATH HAD NOT MOVED AT ALL. THE PATIENT DID NOT HAVE ANY PATIENT ANATOMY ANOMALIES. THE INTRODUCER SHEATH WAS A GORE DRY SEAL WITH A AMPLATZ SUPER STIFF GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320891 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18F-US 0007047733

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Required Intervention