BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GUIDE WIRE

    MDR report key: 3030754 · Received April 2, 2013

    Report

    Report Number
    3003775027-2013-00014
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. CONCOMITANT PRODUCTS: GUIDE WIRE: PROWATER X2, FIELDER FC X5, SION X4, MIRACLE BROS 3 X1, FIELDER XT X1. FROM THE PROVIDED INFORMATION, THE RELATION BETWEEN THE GUIDE WIRE AND OBSERVED PERFORATION COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, SEVERAL ABBOTT GUIDE WIRES WERE USED IN AN ATTEMPT TO CROSS THE CTO AND A PERFORATION OCCURRED WHICH CAUSED AN ARTERIOVENOUS FISTULA. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED TO TREAT THE PERFORATION AND FISTULA. POST PROCEDURE, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH CHEST DISCOMFORT, HYPOTENSION, ANEMIA AND CARDIAC TAMPONADE. ONE DAY POST PROCEDURE, CARDIAC ENZYMES WERE ELEVATED AND A MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION. MEDICATIONS AND FLUIDS WERE USED TO TREAT THE HYPOTENSION. PULMONARY EDEMA WAS NOTED ON (B)(6) 2013, RELATED TO FLUID OVERLOAD WHILE TREATING THE HYPOTENSION, AND WAS TREATED WITH MEDICATIONS. ON (B)(6) 2013, THE PATIENT EXPERIENCED A WORSENING OF HIS CHRONIC CHEST PAIN. THE PATIENT'S CHEST PAIN WAS TREATED WITH MEDICATIONS. NO TREATMENT WAS PROVIDED FOR THE ENZYME ELEVATION AND MI, AS THE ELEVATION BEGAN RESOLVING WHEN THE PERICARDIAL EFFUSION WAS TREATED. THE PERFORATION/FISTULA RESOLVED THE SAME DAY, PERICARDIAL EFFUSION RESOLVED THE FOLLOWING DAY, THE MI RESOLVED ON (B)(6) 2013, THE EDEMA RESOLVED ON (B)(6) 2013, THE CHEST PAIN RESOLVED ON (B)(6) 2013 AND THE HYPOTENSION CONTINUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134135 ASAHI GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R| S