BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PRECISION ACCESS SYSTEM

    MDR report key: 7635662 · Received June 25, 2018

    Report

    Report Number
    1118880-2018-00060
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 12, 2018
    Report Date
    June 25, 2018
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701010793
    PMA / PMN Number
    K111606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. 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 PROVIDE THE DEVICE RETURN DATE AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 7FR IK PRECISION SHEATH WAS RECEIVED FOR PRODUCT EVALUATION. THE SHEATH WAS RECEIVED WITH THE DILATOR. THE RETURNED COMPONENTS WERE SUBJECTED TO VISUAL ANALYSIS. THERE WERE NO GROSS ANOMALIES NOTED WITH THE SHEATH. THE DILATOR WAS EXAMINED AND THERE WAS DAMAGE AT THE DISTAL TIP OF THE DILATOR. MICROSCOPY CONFIRMED THE DILATOR TIP HAD DAMAGE AND THE TIP WAS PARTIALLY OCCLUDED. TO CHECK FOR DAMAGE TO THE VALVE, THE CROSSCUT VALVE WAS DISSECTED FROM THE SHEATH. THE TOP AND BOTTOM SIDE OF THE VALVE WERE INSPECTED. THERE WERE NO ANOMALIES NOTED WITH THE VALVE. THE INNER LUMEN OF THE HUB WAS INSPECTED TO SEE IF ANY ANOMALIES SUCH AS THE KABURI EFFECT OR FOLDING OF THE SHEATH OVER THE CAULKING PIN, WERE PRESENT. NO ANOMALIES WERE NOTED WITH THE INNER LUMEN OF THE HUB. THE COMPLAINT COULD BE CONFIRMED FOR DILATOR TIP DAMAGE. BASED ON THE TIP DAMAGE, THE DILATOR APPEARS TO HAVE COME INTO CONTACT WITH A HARD SURFACE SUCH AS AN OPERATING TABLE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PERIPHERAL A IK DEVICE WAS USED. THE SHEATH WAS FLUSHED AND THE WATER SEEMED TO COME OUT OF NUMEROUS HOLES. THE DEVICE WAS NOT USED ON THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 6/14/18: IT WAS REPORTED THAT SALINE SHOT OUT THE SIDES OF THE SHEATH. NO OTHER DAMAGES WERE FOUND ON THE DEVICE. THERE WAS NO BLOOD LOSS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476296 PINNACLE PRECISION ACCESS SYSTEM INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A WD14 00389701010793

    Patients

    Seq Age Sex Outcome Treatment
    1