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

Model Number 466F210A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information to include from section phone number: (b)(6).The products were not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use, the optease ivc filter encountered resistance during the releasing process and a barbed filter on top of the sheath was noticed.There was no patient injury.Another ivc filter was used to complete the procedure.The target lesion was with thrombus but did not exhibit tortuosity, calcification or stenosis.The product was stored, handled, inspected and prepped according to the instruction for use (ifu) with nothing unusual or damages noted about the delivery sheath prior to use.The device package was not damaged.Excessive force was not used when the device was removed from the packaging.There was no excessive force used during the procedure.The device will not be returned for analysis.

Manufacturer Narrative

The optease ivc (inferior vena cava) filter encountered resistance during the releasing process and a barbed filter on top of the sheath was noticed.There was no patient injury.Another ivc filter was used to complete the procedure.The target lesion was with thrombus but did not exhibit tortuosity, calcification or stenosis.The product was stored, handled, inspected and prepped according to the instruction for use (ifu) with nothing unusual or damages noted about the delivery sheath prior to use.The device package was not damaged.Excessive force was not used when the device was removed from the packaging.There was no excessive force used during the procedure.The device was returned for analysis.A non-sterile unit of product optease retrievable vena cava filter was returned for analysis inside a plastic bag.Per visual analysis the components returned are: a filter already inserted into the tube storage, one vessel dilator, the obturator and the csi (catheter sheath introducer).No perforated sheath condition was noted.No damages or anomalies were noted in the returned parts.Per functional analysis the vessel dilator and the csi were flushed with water.A syringe was attached (filled with water) at the hub of both components to be flushed and the water flowed through the parts and got out at the distal tip as expected.No resistance or obstruction at both devices was noted during the flushing test.A lab sample guidewire of the appropriate size was inserted into the vessel dilator through the distal tip, until it could be viewed outside of the hub.The lab sample guidewire was withdrawn from the catheter.No anomalies were noted during the insertion/withdrawal test.The vessel dilator with the guidewire inside was inserted into the returned csi via the cap and they were introduced as a single unit completely into the cannula.Then both parts were withdrawn completely from the csi.No anomalies were noted during the insertion/withdrawal test.The storage tube with the filter inside was inserted into the hub of the csi.The obturator was inserted through the proximal end of the protective tube of the filter.The obturator pushed the filter and it moved inside the csi until it was unloaded from the cannula without any obstruction or resistance.The insertion filter functional test was carried out successfully, the obturator was advanced through the csi until the filter exited out through the distal end.No resistance or obstruction was noted.Per microscopic analysis the optease filter and filter barbs were inspected and no anomalies or damages were noted.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿balloon burst-at/below rbp¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully.According to the precautions in the safety information in the instructions for use ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ the exact cause of the reported event could not be determined.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.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• 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: 8603504
• MDR Text Key: 144837064
• Report Number: 9616099-2019-02927
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 76