BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY JP IMAGING CATHETER

    MDR report key: 5138894 · Received October 8, 2015

    Report

    Report Number
    3009600098-2015-00003
    Event Type
    Injury
    Date Received
    October 8, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    ORD
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CATHETER BATCH NUMBER WAS NOT PROVIDED TO PERFORM A DEVICE HISTORY RECORD REVIEW. NO CASE OCT PULLBACK OR ANGIOGRAPHY DATA WAS PROVIDED FOR REVIEW. COMMUNICATION WAS RECEIVED THAT NO ADDITIONAL INFORMATION WILL BE MADE AVAILABLE. BASED ON THE INFORMATION PROVIDED THE INVESTIGATION WAS LIMITED AND THE INVESTIGATION RESULTS ARE INCONCLUSIVE. THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN. THE DRAGONFLY JP IMAGING CATHETER DEVICE INSTRUCTION FOR USE (IFU) WARNS AND CAUTIONS THE USER TO USE THE MINIMUM FLUSH RATE AND VOLUME REQUIRED TO IMAGE THE DESIRED ANATOMY. THE DRAGONFLY JP IMAGING CATHETER DEVICE INSTRUCTION FOR USE (IFU) WARNS AND CAUTIONS THE USER TO REFER TO THE CONTRAST MEDIA INSTRUCTIONS FOR USE AND GENERAL WARNINGS AND PRECAUTIONS RELATING TO CONTRAST MEDIA. THE DRAGONFLY JP IMAGING CATHETER DEVICE INSTRUCTION FOR USE (IFU) STATES THAT LARGE THROMBUS IS A CONTRAINDICATION FOR USE OF A DRAGONFLY JP IMAGING CATHETER WHERE INTRODUCTION OF ANY CATHETER WOULD CONSTITUTE A THREAT TO PATIENT SAFETY. THE DRAGONFLY JP IMAGING CATHETER DEVICE INSTRUCTION FOR USE (IFU) STATES THAT ABNORMAL HEART ARRHYTHMIAS ARE A COMPLICATION THAT MAY OCCUR AS A CONSEQUENCE OF INTRAVASCULAR IMAGING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE ARTICLE, "PERIPROCEDURAL MYOCARDIAL INJURY AND RIGHT BUNDLE BRANCH BLOCK DURING CORONARY OPTICAL COHERENCE TOMOGRAPHY IN AN ACUTE CORONARY SYNDROME PATIENT WITH SEVERE CORONARY ECTASIA," WHICH WAS PUBLISHED TO INTERNATIONAL JOURNAL OF CARDIOLOGY 177 (2014) 1113-1115 AND AVAILABLE ONLINE ON (B)(6) 2014: A PATIENT WITH UNSTABLE ANGINA AND CHEST PAIN UNDERWENT EMERGENT CORONARY ANGIOGRAPHY (CAG) WHICH SHOWED A FILLING DEFECT AT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH FLOW LIMITATION. A DRAGONFLY CATHETER WAS USED DURING OCT TO EVALUATE THE FILLING DEFECT AND DEMONSTRATED A THROMBUS PROTRUDING INTO THE DILATED VESSEL. CONTINUOUS INJECTIONS OF ISO-OSMOLAR CONTRAST FLASH AT 3.5ML/S WERE REQUIRED FOUR TIMES TO CLEAR THE OCT IMAGE DUE TO CORONARY ECTASIA. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF CHEST DISCOMFORT. AN ELECTROCARDIOGRAM TEST REVEALED COMPLETE RIGHT BUNDLE-BRANCH BLOCK, REQUIRING ISOSORBIDE DINITRATE AND NICORANDIL. A CAG CONFIRMED THAT THERE WERE NO STRUCTURAL CHANGES IN THE LAD ARTERY OR DISTAL EMBOLISM. THE AUTHOR ALLEGED THAT CONTRAST FLUSHING REQUIRED FOR THE OCT ACQUISITION MAY HAVE CONTRIBUTED TO MYOCARDIAL INJURY. HTTP://DX.DOI.ORG/10.1016/J.IJCARD.2014.08.082.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667303 DRAGONFLY JP IMAGING CATHETER INTRAVASCULAR IMAGING CATHETER ORD ST. JUDE MEDICAL C408648

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R