BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSION PULSIOCATH THERMODILUTION CATHETERS

    MDR report key: 5117103 · Received October 1, 2015

    Report

    Report Number
    3003263092-2015-01001
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    March 24, 2014
    Report Date
    September 7, 2015
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K072364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVOLVED GUIDEWIRE WAS RETURNED FOR INVESTIGATION. DURING OUR INVESTIGATION, THE DIMENSIONS OF THE GUIDEWIRE WERE MEASURED AND COMPARED WITH A REFERENCE GUIDEWIRE OF PULSION MEDICAL SYSTEMS. AS THE RETURNED GUIDEWIRE DOES NOT MEET THE SPECIFICATIONS OF A GUIDEWIRE FROM PULSION MEDICAL SYSTEMS SE IN LENGTH, BUT THE POSITIONING OF THE COATING MATCHES, IT CAN BE ASSUMED THAT IS LIKELY THE RETURNED GUIDEWIRE IS A PICCO GUIDEWIRE MANUFACTURED BY PULSION MEDICAL SYSTEMS. THE ROOT CAUSE FOR THE MISSING ENDS COULD NOT BE DETERMINED. AS THE GUIDEWIRE WAS LEFT INSIDE THE PATIENT MORE THAN 22 MONTHS AND NOT WITHDRAWN RIGHT AFTER FINAL PLACEMENT OF THE CATHETER ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THIS IS SEEN AS AN USER ERROR. A DHR REVIEW COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A CEREBRAL HEMORRHAGE AND DURING RECOVERY, HE HAD A PICCO-CATHETER INSERTED. AFTER SOME WEEKS, THE PATIENT LEFT THE HOSPITAL. AFTER APPROXIMATELY ONE YEAR, THE PATIENT SUDDENLY LOST HIS VOICE AND THE EXAMINATION AT THE DOCTOR¿S OFFICE SHOWED A LATERAL RECURRENS PARESIS. LATER ON, X-RAY PRESENTED A GUIDEWIRE ON ITS WAY OUT OF A. CAROTIDS, PUSHING ON THE N. RECURRENT ON THE LEFT SIDE. THE GUIDEWIRE WAS REMOVED AND THE PATIENT IS NOW HEALTHY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL DESCRIPTION OF EVENT : PICCO CATHETER WAS INSERTED INTO THE PATIENT ON (B)(6) 2012 AND WITHDRAWN THE DAY AFTER, ON (B)(6) 2012. DURING THE SPRING OF 2014, THE PATIENT EXPERIENCED PROGRESSIVELY INCREASING HOARSENESS. ON (B)(6) 2014 THE GUIDEWIRE (USED FOR THE INSERTION OF THE CATHETER) WAS SURGICALLY REMOVED THROUGH INCISION ON THE LEFT SIDE OF THE PATIENT'S THROAT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646634 PULSION PULSIOCATH THERMODILUTION CATHETERS PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE PV2015L20-N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention