MAUDE Adverse Event Report: CORDIS US. CORP OPTEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F210A

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18113974 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was resistance encountered while attempting to deliver a 55cm optease retrievable vena cava filter through the included catheter sheath introducer (csi) and the outer sheath of the csi was punctured by the filter during attempted deployment.The filter and csi were easily removed together as a unit, and an unknown filter, along with an unknown sheath were used as a replacement to complete the procedure.There were no reported injuries or adverse events to the patient.The filter was being implanted due to acute deep vein thrombosis (dvt) resulting in swelling of the lower limbs, which was identified via computed tomography (ct).The device was stored and prepped per the instructions for use (ifu).A femoral approach was made with the included csi and the vessel dilator was kept in the csi until the desired deployment location was reached.The filter was never in an acute bend during delivery and the sheath was not kinked.The device will be returned for evaluation.

Manufacturer Narrative

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

Event Description

As reported, there was resistance encountered while attempting to deliver a 55cm optease retrievable vena cava filter through the included catheter sheath introducer (csi) and the outer sheath of the csi was punctured by the filter during attempted deployment.The filter and csi were easily removed together as a unit, and an unknown filter, along with an unknown sheath were used as a replacement to complete the procedure.There were no reported injuries or adverse events to the patient.The filter was being implanted due to acute deep vein thrombosis (dvt) resulting in swelling of the lower limbs, which was identified via computed tomography (ct).The device was stored and prepped per the instructions for use (ifu).A femoral vein approach was made with the included csi and the vessel dilator was kept in the csi until the desired deployment location was reached.The filter was never in an acute bend during delivery and the sheath was not kinked.The device will be returned for evaluation.

• Brand Name: OPTEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17669475
• MDR Text Key: 322478494
• Report Number: 9616099-2023-06590
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009390
• UDI-Public: (01)20705032009390(17)250430(10)18113974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 466F210A
• Device Lot Number: 18113974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CSI; UNKNOWN FILTER
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian