BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 4994774 · Received July 31, 2015

    Report

    Report Number
    3003263092-2015-00016
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    May 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO REC'D INFORMATION THE PICCO CATHETER WAS DISCARDED. TESTS PERFORMED ON CATHETERS FROM THE SAME BATCH DID NOT REVEAL ANY NON-CONFORMITY THAT COULD CONTRIBUTE TO A HIGHER RISK OF THROMBOSIS WITH PICCO CATHETERS. IN ADDITION HAEMOCOMPATIBILITY TESTS COULD EXCLUDE THAT A POTENTIAL THROMBOGENICITY OF THE INVOLVED DISPOSABLES (DILATOR, GUIDEWIRE, CATHETER), WHICH COULD CONTRIBUTE TO AN INCREASE OF THE RISK OF THROMBOSIS, IS PRESENT. THE INSTRUCTIONS FOR USE (IFU) HAVE SEVERAL INDICATIONS ABOUT THE RISK OF THROMBOSIS AND EMBOLISM. THE IFU INDICATES PRECISELY HOW CONTROL OF THE PERFUSION SHOULD BE PERFORMED WHEN CATHETER IS PLACED. THE CONCLUSION IS THAT THERE WERE NO MALFUNCTIONS, FAILURES OR CHANGES IN THE CHARACTERISTICS OR THE PERFORMANCE OR AN INADEQUACY IN THE LABELING OR THE INSTRUCTIONS OF THE MEDICAL DEVICE THAT HAS CONTRIBUTED TO THE REPORTED THROMBOSIS. THE INCIDENT IS CONSIDERED AS A KNOWN COMPLICATION OF ARTERIAL CANNULATION. PLEASE NOTE, THIS EVENT IS BEING FILED AS A RETROSPECTIVE MDR AS A RESULT OF A REVIEW OF OUR COMPLAINT DATABASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PICCO CATHETER WAS PLACED IN THE BRACHIAL ARTERY OF A PATIENT BEFORE HIPEC (HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY) PROCEDURE. AFTER 16 HOURS ISCHEMIA WAS NOTICED IN LOWER ARM OF THE PATIENT AND FORMATION OF THROMBOSIS AROUND THE CATHETER WAS CONFIRMED BY ECHO. THE THROMBOSIS HAS TO BE REMOVED SURGICALLY (THROMBECTOMY). THE FINAL PATIENT OUTCOME WAS NO INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501936 PULSION PULSIOCATH THERMODILUTION CATHETERS KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention