BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGELLAN ROBOTIC CATHETER

    MDR report key: 5608900 · Received April 26, 2016

    Report

    Report Number
    3006026430-2016-00002
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    October 9, 2015
    Report Date
    April 21, 2016
    Manufacturer
    HANSEN MEDICAL INC.
    Product Code
    DRA
    PMA / PMN Number
    K133552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IFU LISTS PERFORATION AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE. THE ADVERSE EVENTS LISTED IN THE IFU ARE SIMILAR TO THOSE EXPECTED WITH MANUAL VASCULAR CATHETER, GUIDE WIRES, GUIDING SHEATHS, AND GUIDING CATHETERS. THE CATHETER WAS UNABLE TO BE EVALUATED BECAUSE IT WAS DISCARDED. ALL MAGELLAN CATHETERS ARE 100% INSPECTED AND EVALUATED PRIOR TO FINAL RELEASE. FROM THE INFORMATION PROVIDED BY THE PHYSICIAN AND HOSPITAL, HANSEN MEDICAL IS UNABLE TO DETERMINE THE CAUSE OF THE EVENT. CATHETER DISCARDED BY SITE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY-R AND PROFUNDA-FEMORAL-R ARTERY. PATIENT HAD STENTING TREATMENT OF THE SFA AND AN ANGIOPLASTY OF THE PROFUNDA ARTERY PERFORMED THROUGH THE ROBOTIC CATHETER. GUIDE WIRES, BALLOONS AND STENTS USED DURING THE PROCEDURE WERE NOT MANUFACTURED OR PROVIDED BY HANSEN MEDICAL. DURING THE PROCEDURE THE PATIENT EXPERIENCED A PERIPHERAL PERFORATION. BLEEDING WAS DISCOVERED AFTER SURGERY WHILE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT (PACU). PATIENT COMPLAINED OF RIGHT THIGH PAIN. ASSESSMENT REVEALED TIGHT, SWOLLEN THIGH. BEDSIDE ULTRASOUND WAS USED TO CONFIRM BLEEDING. SITE WAS UNABLE TO DETERMINE THE SPECIFIC LOCATION OF THE PERFORATION. TREATED WITH ACE WRAP COMPRESSION, INTRAVENOUS FLUIDS, AND BLOOD TRANSFUSION. BLEEDING RESOLVED BEFORE RESIDENT EVALUATED THE PATIENT THE NEXT DAY. THE EVENT RESOLVED WITH NO SEQUELAE. ON (B)(6) 2015, PATIENT HAD POST PROCEDURE FOLLOW-UP WITH NO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262101 MAGELLAN ROBOTIC CATHETER MRC 6FR 1.1 LONG CATHETER DRA HANSEN MEDICAL INC. 22658 20150407

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention COOK MEDICAL BALLOON