MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

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

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

There was difficulty when advancing an optease filter and it punctured the sheath during delivery of the filter through the sheath.The filter was withdrawn and replaced with another one to complete the procedure.The patient was not morbidly obese, and the approach was not tortuous.The product was stored and handled per ifu.There was no difficulty prepping the devices.The sheath was flushed prior to insertion into the patient and there was no difficulty inserting the filter into the sheath.There was no excessive force used.The filter was no longer within the storage tube when it punctured the delivery sheath.The device was discarded.Patient information was requested but was not available.

Manufacturer Narrative

There was difficulty when advancing the optease retrievable filter and it punctured the sheath during delivery of the filter.The filter was withdrawn and replaced with another sheath to complete the procedure.The filter was placed for deep vein thrombosis.The patient was not morbidly obese and the approach was not tortuous.The product was stored and handled per instructions per use (ifu).There was no difficulty prepping the devices.The sheath was flushed prior to insertion into the patient and there was no difficulty inserting the filter into the sheath.There was no excessive force used.The filter was no longer within the storage tube when it punctured the delivery sheath.The device was discarded.The product was not returned for analysis.A product history record (phr) review of lot 17911452 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter impeded - perforated sheath¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Based on the information available for review, procedural factors, such as operator technique, may have contributed to the event.According to ifu, which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11087708
• MDR Text Key: 225307986
• Report Number: 9616099-2020-04155
• 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
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17911452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1