BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 3182947 · Received June 21, 2013

    Report

    Report Number
    3003775027-2013-00030
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE: REPORTED AS 08/2015. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS BEING RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION OR DEVICE RETURN HAS BEEN RECEIVED FROM THE SITE. DEVICE INVESTIGATION COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. WITH THE INFORMATION PROVIDED, WE COULD NOT DETERMINE IF OR NOT THE GUIDE WIRE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EXPIRATION DATE REPORTED AS 08/2015. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.ATTACHMENT: USER FACILITY MANDATORY MEDWATCH REPORT NUMBER 3933070000-2013-8001. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT: STATES, "CARDIAC CATH PROCEDURE COMPLETED FOR PATIENT THAT HAD HETEROTAXY, DESTROCARDIA, DISCONTINUOUS BRANCH OF PULMONARY ARTERY WITH SUBSEQUENT POST-SURGICAL REPAIR AND PROGRESSIVE HYPOXIA FOR THE 3 DAYS PRIOR TO THE CATH. THE PROXIMAL LEFT PULMONARY ARTERY WAS SEVERELY STENOTIC AND THE PATIENT WAS TO HAVE STENTS PLACED; FOLLOWING THE STENT ANGIOPLASTY THE WIRE USED TO PLACE THE STENT COULD NOT BE WITHDRAWN. IT WAS DECIDED BY THE PHYSICIAN TO KNOT THE END, AND SUTURE THE CATHETER TO THE LEFT LEG. APPROXIMATELY 1CM OF THE CATHETER WAS RETAINED IN A SMALL BRANCH OF THE PULMONARY ARTERY. THE DISTAL END OF THE WIRE WAS REMOVED 3 DAYS LATER IN THE CATH LAB. THE RETAINED PORTION COULD NOT BE REMOVED." NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED VIA VOLUNTARY MEDWATCH REPORT: STATES, "CARDIAC CATH PROCEDURE COMPLETED FOR PATIENT THAT HAD HETEROTAXY, DESTROCARDIA, DISCONTINUOUS BRANCH OF PULMONARY ARTERY WITH SUBSEQUENT POST-SURGICAL REPAIR AND PROGRESSIVE HYPOXIA FOR THE 3 DAYS PRIOR TO THE CATH. THE PROXIMAL LEFT PULMONARY ARTERY WAS SEVERELY STENOTIC AND THE PATIENT WAS TO HAVE STENTS PLACED; FOLLOWING THE STENT ANGIOPLASTY THE WIRE USED TO PLACE THE STENT COULD NOT BE WITHDRAWN. IT WAS DECIDED BY THE PHYSICIAN TO KNOT THE END, AND SUTURE THE CATHETER TO THE LEFT LEG. APPROXIMATELY 1CM OF THE CATHETER WAS RETAINED IN A SMALL BRANCH OF THE PULMONARY ARTERY. THE DISTAL END OF THE WIRE WAS REMOVED 3 DAYS LATER IN THE CATH LAB. THE RETAINED PORTION COULD NOT BE REMOVED." SUBSEQUENT INFORMATION RECEIVED STATED A SECOND PROCEDURE WAS PERFORMED, HOWEVER, THE GUIDE WIRE FRAGMENT REMAINS IN THE ANATOMY. THE PATIENT WAS REPORTED AS LIVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283014 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 120905A15S

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA Hospitalization| R