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

Catalog Number 466F210AF

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

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

As reported, during implantation of a 55cm optease inferior vena cava (ivc) filter implantation, in the process of pushing in the release sheath, the anti-migration barb punctured the release sheath, and the filter could not be used normally.The operator then withdrew the release sheath with the filter and replaced it with a new optease filter to complete the release.The patient was not harmed during the procedure.There was no reported patient injury.The filter was indicated for deep vein thrombosis (dvt) of the lower limbs.The size of the vena cava was measured at about 20 mm in diameter; the shape was normal without obvious tortuosity; mild vessel calcification and no acute bends.The product was stored, handled, and prepped according to the instructions for use (ifu).The device was checked prior to use and there were no anomalies noted.There were no visible signs of packaging damage prior to use and no unusual force was used at any time during the procedure.The catheter did not kink or bend at any time prior to the resistance friction.There was no difficulty or resistance friction while advancing the deployment sheath.The catheter sheath introducer (csi) included in the kit was used for the procedure.The device was returned for evaluation.

Manufacturer Narrative

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

• Brand Name: OPTEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18975617
• MDR Text Key: 339356436
• Report Number: 9616099-2024-00083
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F210AF
• Device Lot Number: 18262794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2023
• 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: 6F AVANT PLUS UNKNOWN SHEATH
• Patient Age: 72 YR
• Patient Sex: Female