MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F210A

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 55 optease retrievable vena cava filter was intended to be used to perform a vena cava filter implantation with deep vein thrombosis (dvt) of the lower extremity.The catheter sheath was used to perform an angiography.After the catheter sheath was placed below the opening of the renal vein, it was found that the contrast agent could not be injected and there was an obvious blockage was obtained in the cavity.Therefore, the operation was suspended and a new optease filter was used to proceed with the operation.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

A 55 optease retrievable vena cava filter was intended to be used to perform a vena cava filter implantation with deep vein thrombosis (dvt) of the lower extremity.The catheter sheath was used to perform an angiography.After the catheter sheath was placed below the opening of the renal vein, it was found that the contrast agent could not be injected and there was an obvious blockage was obtained in the cavity.Therefore, the operation was suspended and a new optease filter was used to proceed with the operation.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17886081 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿cannula (csi/filters) obstructed - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of the possible presence (although unknown) may have contributed to the reported event.According to the safety information in the instructions for use ¿precautions if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.Caution: do not use with ethiodol or lipiodol contrast media, or other such contrast media, which incorporate the components of these agents.Caution: do not exceed 800 psi when injecting through a power injector.Ensure that a high-pressure connection line is used.Caution: to avoid damage to the sheath introducer tip, do not withdraw the dilator until the sheath introducer tip is at the desired location in the ivc.Caution: do not leave a sheath introducer in place for extended periods of time without a dilator or an obturator to support the cannula wall.¿ neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

A 55cm optease retrievable vena cava filter was intended to be used to perform a vena cava filter implantation with deep vein thrombosis (dvt) of the lower extremity.The catheter sheath was used to perform an angiography.After the catheter sheath was placed below the opening of the renal vein, it was found that the contrast agent could not be injected and there was an obvious blockage was obtained in the cavity.Therefore, the operation was suspended and a new optease filter was used to proceed with the operation.There was no reported patient injury.The product was returned analysis.One non-sterile optease retrievable filter 55cm was received inside of two clear plastic bags, one of them with the optease device inside the pouch and the other with the sheath introducer and the vessel dilator.Per visual analysis the optease was not taken out of the pouch, this was still sealed.The sheath introducer and its vessel dilator were in good condition.No anomalies were observed on the components returned.Per functional analysis flushing and insertion tests were successfully performed.On both tests, attention was paid if any material was ejected from the device that could be obstructing, but no material was detected.A product history record (phr) review of lot 17886081 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿cannula (csi/filters) - obstructed - in patient¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully.The exact cause of the reported event could not be determined.According to the instructions for use, which are not intended as a mitigation of risk ¿remove air from the sheath introducer by flushing with heparinized saline or suitable isotonic solution.Insert the angiographic vessel dilator through the sheath introducer hemostasis valve, snapping it into place at the hub.Flush with heparinized saline or suitable isotonic solution.Aspirate from the sideport extension to remove any potential air.¿ the device performed as intended and therefore the reported event could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time at this time.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 9716788
• MDR Text Key: 199860734
• Report Number: 9616099-2020-03525
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17886081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1