BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 90CM-EU

    MDR report key: 2770052 · Received October 3, 2012

    Report

    Report Number
    9616099-2012-00545
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMPLAINT CONCLUSION: AS IT WAS REPORTED BY AN AFFILIATE WHILE ADVANCING THE FILTER THROUGH THE DELIVERY SHEATH IT BECAME STUCK, ONE OF THE BARBS HAD PERFORATED THE SHEATH AND THE FILTER WOULD ADVANCE NO FURTHER. THERE WAS NO REPORTED PATIENT INJURY. A NEW IVC FILTER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ONE NON STERILE 6 FR. SHEATH INTRODUCER, ONE NON STERILE 6 FR. OBTURATOR AND ONE FILTER CARTRIDGE WERE RECEIVED. THE FILTER WAS RECEIVED INSIDE THE CANNULA. ONE BARB FROM THE FILTER PERFORATES THE CANNULA. NO OTHER ANOMALIES WERE FOUND ON THE RETURNED UNITS. FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE FILTER WAS ALREADY INSIDE THE CANNULA AND THE FILTER BARB WAS DAMAGED. THE OD AND ID OF THE BODY WERE MEASURED NEAR TO THE PERFORATION POINT AND WERE FOUND WITHIN SPECIFICATION. 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 ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED DURING ANALYSIS. THE CAUSE THAT THE BARB PERFORATES THE CANNULA COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THAT THE CANNULA LEAVES THE FACILITY WITH DAMAGES. PROCEDURAL OR CLINICAL FACTORS MIGHT HAVE IMPACTED THE EVENT. NO CORRECTIVE ACTION WILL TAKEN AT THIS TIME SINCE NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGEST THAT THE FAILURE EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS, DEVICE INTERACTION AND/OR USER HANDLING.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY AN AFFILIATE, DURING A PROCEDURE, AN IVC FILTER PERFORATED AND WAS JAMMED IN THE 6F DELIVERY SHEATH. WHEN PHYSICIAN TRIED TO DEPLOY THE IVC FILTER, PHYSICIAN INSERTED THE FILTER "FEMORAL" APPROACH, WHICH WAS RIGHT (LEFT FEMORAL ARTERY, ACCESS SITE) . THE FILTER WAS PUSHED AND MOVED TO UP IN THE LONG SHEATH, THE HOOK PERFORATED THE SHEATH. THE VESSEL DID NOT PRESENT ANY ACUTE BENDS OR TORTUOSITY, NO RESISTANCE FRICTION WAS DESCRIBED. THERE WAS NO FOREIGN MATERIAL AT THE LEVEL OF THE DIFFICULTY. THERE WAS NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE RETRIEVABLE VENA CAVA FILTER - 90CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA 15430939

    Patients

    Seq Age Sex Outcome Treatment
    1