BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETR FILTER 55 FEMORAL

    MDR report key: 7826969 · Received August 29, 2018

    Report

    Report Number
    9616099-2018-02351
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 19, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN OPTEASE VENA CAVA FILTER WAS ATTEMPTED TO BE INSERTED BUT THE DISTAL END MARKER OF ITS SHEATH WAS FRAYED AND TURNED OUTWARDS. IT WAS REPLACED WITH A NEW PRODUCT TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. A NON-STERILE OPTEASE RETRIEVABLE FILTER CANNULA SHEATH INTRODUCER (CSI) AND A VESSEL DILATOR WERE RECEIVED FOR ANALYSIS INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE VESSEL DILATOR WAS RECEIVED FULLY INSERTED INTO THE CANNULA SHEATH. THE CANNULA SHEATH INTRODUCER WAS RECEIVED WITH FRAYED/ SPLIT/ TORN DAMAGED ON THE TIP OF THE UNIT. THE ORIGINAL PACKAGING WAS NOT RETURNED FOR ANALYSIS; THEREFORE MAKING IT UNABLE TO DETERMINE IF THE OBSERVED DAMAGE CONDITION WAS DUE TO IMPROPER PACKAGING. DRIED BLOOD RESIDUES WERE ALSO OBSERVED ON THE TIP OF THE CANNULA SHEATH. NO OTHER ANOMALIES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE EVENT REPORTED BY THE CUSTOMER AS ¿BRITE TIP (CSI/FILTERS)- FRAYED/SPLIT/TORN¿ WAS CONFIRMED. A FRAYED/SPLIT/TORN CONDITION WAS FOUND ON THE CANNULA SHEATH. HOWEVER, THE EXACT CAUSE OF THE CONDITION FOUND COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. ANALYSIS RESULTS AND PHR REVIEW RESULTS DO NOT SUGGEST THAT THIS DAMAGE IS RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS, (SUCH AS INTERACTION OF THE CANNULA SHEATH WITH A CONCOMITANT VESSEL DILATOR OR GUIDE WIRE) MAY CONTRIBUTE TO THE FAILURE AS REPORTED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿A VESSEL DILATOR FACILITATES THE PERCUTANEOUS ENTRY OF THE CSI BY FORMING AN ATRAUMATIC TRANSITION FROM THE SKIN THROUGH THE SUBCUTANEOUS TISSUE TO THE VESSEL. IF INCREASED RESISTANCE IS FELT UPON INSERTION OF THE CSI, INVESTIGATE THE CAUSE BEFORE CONTINUING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED AND CORRECTED, DISCONTINUE THE PROCEDURE AND WITHDRAW THE CSI.¿ BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(6). THE DEVICE WAS RETURNED BUT THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AN OPTEASE VENA CAVA FILTER WAS ATTEMPTED TO BE INSERTED BUT THE DISTAL END MARKER OF ITS SHEATH WAS FRAYED AND TURNED TOWARDS OUT. THEREFORE, IT WAS REPLACED WITH A NEW PRODUCT TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666944 OPTEASE RETR FILTER 55 FEMORAL THROMBECTOMY SYSTEMS DTK CORDIS CASHEL N/A 17755556

    Patients

    Seq Age Sex Outcome Treatment
    1