BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE FX DELIVERY SYSTEM

    MDR report key: 2900445 · Received January 7, 2013

    Report

    Report Number
    2135147-2013-00001
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K121611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: PT SEX: FEMALE. EXPIRATION DATE 8/31/2015. VOLUNTARY MEDWATCH SUBMITTED BY USER FACILITY, COPY RECEIVED BY SJM (B)(4) 2013 ((B)(4)). DEVICE ANALYSIS: THE TVFX CABLE (OUTER CORE WIRE) WAS RETURNED TO SJM WITH THE MALE END SCREW MISSING AND FRACTURED FROM THE REMAINDER OF THE RETURNED CABLE. THE NITINOL CORE WIRE WAS EXAMINED AND THE FRACTURE SURFACE WAS FOUND TO BE SMOOTH WITH EVIDENCE OF TORSIONAL FAILURE. ALL COMPONENTS WERE RETURNED WITHIN SPECIFICATION, EXCEPT THE FRACTURE, AND THE FAILURE WAS DEEMED TO BE NOT RELATED TO MANUFACTURING. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING SIMULATED USE BY ATTACHING AND DETACHING A THREAD GAGE TO THE DELIVERY CABLE END SCREW. REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM SUCCESSFULLY PASSED THESE INSPECTIONS.

    Description of Event or Problem · 1

    A 12F AMPLATZER TORQVUE FX 45 DELIVERY SYSTEM (TVFX45) WAS USED TO IMPLANT A 28MM AMPLATZER SEPTAL OCCLUDER (ASO). (A 10F TVFX45 IS RECOMMENDED FOR USE WITH A 28MM ASO.) THE PLACEMENT OF THE ASO WAS CHALLENGING AND REQUIRED MULTIPLE DEPLOYMENTS AND RETRIEVALS. AFTER MULTIPLE ATTEMPTS, THE ASO ADEQUATELY CAPTURED THE ATRIAL SEPTUM. THE DELIVERY CABLE (OUTER CORE WIRE) WAS RETRACTED AND DEVICE POSITION WAS CONFIRMED. THE INNER CORE WIRE WAS TURNED COUNTERCLOCKWISE BUT THE DEVICE DID NOT RELEASE. THE OUTER CORE WIRE WAS REPOSITIONED AND PLACED AGAINST THE DEVICE, THE VISE WAS LOCKED IN PLACE AND THE OUTER CORE WIRE WAS TURNED COUNTERCLOCKWISE BUT THE DEVICE STILL DID NOT RELEASE. THE DELIVERY SHEATH WAS POSITIONED CLOSER TO THE DEVICE AND THE VISE WAS TURNED COUNTERCLOCKWISE. THE INNER CORE WIRE RELEASED THE ASO BUT UPON RETRACTING IT INTO THE SHEATH, THE END SCREW BECAME DETACHED AND TRAVELLED TO THE RIGHT VENTRICLE. THE MATERIAL WAS LEFT IN THE VENTRICLE AND THE PATIENT IS BEING CLOSELY MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION WHENEVER A HARLEY DAVIDSON MOTORCYCLE DROVE BY OUTSIDE. THE PATIENT ALSO EXPERIENCED THIS WHEN HE USED HIS MICROWAVE AS WELL AS WHEN HE WENT TO THE STORE. THE REPORTER STATED THAT THE PATIENT WAS NOT USING HIS STIMULATION 'TOO MUCH' AND WAS STILL ON PAIN MEDICATION. IMPEDANCES WERE REPORTED TO BE NORMAL; BETWEEN 900 OHMS AND 1100 OHMS. REPROGRAMMING WAS ALSO DONE. THE PATIENT'S THERAPY WAS WORKING NORMALLY OTHERWISE. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER INDICATED THAT THERE WERE NO MALFUNCTIONS SEEN OR CAUSE OF ISSUE DETERMINED. THERE WERE NO INTERVENTIONS TAKEN OR PLANNED. PATIENT OUTCOME WAS GOING TO BE AVAILABLE IN 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7039 AMPLATZER TORQVUE FX DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITVFX012F45/80 1209133114

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization