BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM

    MDR report key: 7751930 · Received August 6, 2018

    Report

    Report Number
    1118880-2018-00074
    Event Type
    Death
    Date Received
    August 6, 2018
    Date of Event
    July 13, 2018
    Report Date
    August 6, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K121404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL DIFFICULTY OF THE SHEATH FOR THE REPORTED SOLOPATH DEVICE. SEE MDR REPORT NO. 1118880-2018-00083 FOR THE REPORTED DIFFICULT MOBILITY IN THE SHEATH ON THE REPORTED SOLOPATH DEVICE THAT WAS USED ON THE SAME PATIENT AS BEING REPORTED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE DEVICE HISTORY REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO 1) PROVIDE THE EXPIRATION DATE AND UDI NO. IN MODEL #/LOT #, PROVIDE THE DEVICE MANUFACTURER DATE IN DEVICE MFR DATE, AND 3) PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE INVOLVED DEVICE WAS RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION, AND THE RETURNED PHOTOGRAPHS. INSPECTION OF THE PHOTOGRAPHS REVEALED THERE WAS A SECTION IN THE MIDDLE OF THE SHEATH THAT APPEARED PARTIALLY EXPANDED. ADDITIONALLY, THERE WAS A SECTION OF THE SHEATH THAT APPEARED PARTIALLY DEFORMED. THERE WAS AN ACCORDION APPEARANCE OF THE SHEATH AT THIS SECTION. BASED ON THE REPORTED EVENT, THE PATIENT'S VESSELS WERE EXTREMELY CALCIFIED. IT IS LIKELY THE SHEATH BECAME CAUGHT ON CALCIUM AND COULD HAVE CONTRIBUTED TO THE DIFFICULT WITHDRAWAL THE USER EXPERIENCED. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DILATOR WAS DIFFICULT TO WITHDRAWAL WHEN USING THE SOLOPATH DEVICE. THE PATIENT WITH KNOWN SPOBA (PLAIN OLD BALLOON ANGIOPLASTY), RCA (RIGHT CORONARY ARTERY), PERIPHERAL EMBOLI FOR WHICH AORTIC STENT. NOW STABLE ANGINA WITH POSITIVE MIBI SCAN. CHAMBER FUNCTION IS PRETTY GOOD, APICAL ANEURYSM. LOTS OF CALCIUM IN AORTA. GFR (GLOMERULAR FILTRATION RATE ( 32 ML / MIN. ANGIOGRAPHICALLY SEVERELY CALCIFIED 3 VESSEL DISEASE. NOT A CANDIDATE FOR SURGERY. PRE PROCEDURAL ECHO SHOWS ACCESSIBLE FEMORALIS COMMUNIS ON BOTH SIDES WITHOUT SERIOUS STENOSES OR CALCIFICATIONS. UNCOMPLICATED ACCESS LEFT AND RIGHT FEMORAL ARTERIAL AS WELL AS RIGHT RADIAL (7FR) IN CONTEXT OF PULSE STUDY. WORK UP TO 19FR SOLOPATH VIA LEFT FEMORALIS THROUGH CALCIFIED ILIAC TRAJECTORY. UNCOMPLICATED INFLATION OF SOLOPATH. PULSECATHLV SUPPORT CATHETER THEN PASSES DIFFICULTLY, THEREBY VAGAL COLLAPSE WITH RECOVERY RHYTHM AT 2MG ATROPINE. POSSIBLY BY FRICTION IN ILIAC TRAJECTORY. IT WAS DECIDED TO REFRAIN FROM FURTHER STUDY AND TO REMOVE PV (PULMONARY VEIN) LOOP AND PULSECATH INCLUDING THE SOLOPATH SHEATH. THE SOLOPATH SHEATH REMOVAL VERY LABORIOUS WITH MUCH RESISTANCE - EXCHANGING FOR 20FR MDT (MEDTRONIC) SHEATH. A CONTROL ANGIOGRAM SHOWED A LACERATED ILIAC COMMUNIS /EXTERNA FOR WHICH A COVERED STENT WAS PLACED. THIS ONE HOWEVER, DID NOT COMPLETELY CLOSE THE DISSECTION AND THE PATIENT WENT INTO HYPOVOLEMIC SHOCK. THE PATIENT EXPIRED (B)(6) 2018 AT 11.06 AM OF HYPOVOLAEMIC SHOCK DUE TO RETROPERITONEAL HAEMORRHAGE WITH UNDERLYING MORE SEVERE THAN ESTIMATED VASCULAR DISEASE. THE USER FACILITY ALLEGES THAT THE DEVICE FAILED TO EXPAND COMPLETELY. WHEN IT WAS DECIDED THE TAKE OUT THE DEVICES, THE DEFLATION AND REMOVAL OF THE SHEATH DID NOT WORK. AT THIS POINT, THE SOLOPATH BECAME STUCK IN THE ARTERY, PROBABLY DUE TO THE MUCH-CALCIFIED VESSEL. A RELATIVELY HIGH FORCE WAS NECESSARY TO REMOVE THE DEVICES. AFTER THE SOLOPATH CAME OUT OF THE BODY, THE LONGER PART OF THE IVAC 2L WAS JUST REMOVED EASILY, WHICH INDICATED THAT THERE WAS NO FRICTION BETWEEN THIS CATHETER AND THE VESSEL. POST REMOVAL THE SHEATH AND THE IVAC 2L WERE EXAMINED. IT WAS STILL NOT POSSIBLE TO REMOVE THE CATHETER FROM THE SOLOPATH. IT WAS ALLEGED THAT AT THE POINT OF HIGH FRICTION, IN THE MIDDLE OF THE SOLOPATH, A SMALL SHARP BULGE IN THE SHEATH COULD BE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593285 SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A UN16

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death ATROPINE| PULSECATH