MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DTK)

Model Number N/A

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.This is one of two products involved with this event in which associated manufacturer report numbers is 9616099-2016-00103.

Event Description

During treatment to the inferior vena cava (ivc), it was reported that after a sheathe introducer (accessory for optease) was inserted, an optease was attempted to be inserted into the sheath introducer.However the optease became stuck on its way in the sheath and could not be inserted.The sheath was removed from the patient's body and confirmed that the barb was penetrated through the sheath.The optease was exchanged to a new optease and it was tried to be inserted again.However the same issue occurred with the 2nd optease.Therefore it was exchanged to another non-cordis filter and the procedure finished successfully.There was no reported patient injury.The devices were stored, inspected and prepped per ifu.There were no anomalies noted on the devices prior to using them on the patient.There had been difficulties inserting the sheath into the patient with the sheaths.Excessive torquing was e used during insertion.The vessel characteristics at the insertion site are unknown.The products will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: during treatment to the inferior vena cava (ivc), it was reported that after a sheath introducer (accessory for optease) was inserted with difficulty and excessive torquing, an optease was attempted to be inserted into the sheath introducer.However, the optease became stuck on its way in the sheath and could not be inserted.The sheath was removed from the patient¿s body and confirmed that the barb had penetrated through the sheath.The optease was exchanged to a new optease and the user attempted to insert a filter again but the same issue occurred.Therefore, it was exchanged to another non-cordis filter and the procedure finished successfully.There was no reported patient injury.The devices were stored, inspected and prepped per ifu.There were no anomalies noted on the devices prior to using them on the patient.There had been difficulties inserting the sheath into the patient.The vessel characteristics at the insertion site are unknown.Product file (b)(4): a non-sterile unit of 55cm optease for femoral delivery only, was received inside of a plastic bag.An obturator, a csi cannula, a filter and storage tube were received.Storage and csi cannula were received with obturator inserted.The filter was received inside csi cannula at 12.5 cm from distal tip.Two barbs of the filter were observed protruding of the csi cannula (perforations were observed on csi cannula due to filter barbs).A kink condition was observed on the cannula at 8cm from distal tip.Functional analysis was performed and the filter was retrieve from the cannula and was advanced through from csi cannula.It deployed successfully without difficulty despite the kinked condition observed on cannula body.For analysis of reported insertion difficulty into the patient, no functional test can be performed due to nature of the failure.However, the filter and csi cannula were inspected under vision system and no damages were observed on the filter barbs.On the csi cannula, two perforations were observed due to the filter barbs and no damages were observed on the cannula distal tip.The tip is smooth and in good/expected shape.Dimensional analysis was not performed as the filter was advanced through the csi cannula and it was deployed successfully without difficulty.A review of the manufacturing documentation associated lot 17234071 revealed no anomalies during the manufacturing and inspection processes.The complaint reported by the customer as ¿catheter sheath introducer (csi)/insertion difficulty¿ could not be confirmed as the actual conditions of use could not be replicated; however, a visual analysis of the distal tip noted no damages and the tip was smooth and in good shape.Patient factors and or user technique may have contributed to the difficulty obtaining vascular access with the catheter sheath introducer (csi).The reported ¿catheter sheath introducer (csi)/ obstructed: particles cannot be injected¿ was not confirmed as the returned filter was advanced through the csi without difficulty and no obstructions were observed.However, the ¿filter/ impeded-perforated sheath¿ was confirmed as the device was returned with the filter inserted in the csi and barbs penetrating the cannula.Clinical factors contributing to the difficulty experienced by the customer could not be conclusively determined; however, the csi was also received kinked which may suggest that procedural factors may have contributed to this issue.The instructions for use precautions that if strong resistance is met during any stage of the procedure, to discontinue the procedure and determine the cause before proceeding.Neither the analysis nor the dhr suggests a design or manufacturing related cause for the difficulty experienced by the customer; therefore, no corrective actions will be taken at this time.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5466104
• MDR Text Key: 39213485
• Report Number: 9616099-2016-00104
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17234071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1