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 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Telephone number is (b)(6).The device was returned but the engineering report is pending.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when advancing the filter and it punctured the sheath during delivery of the filter through the sheath.The filter was withdrawn and replaced with another one to complete the procedure.The patient was not morbidly obese, and the approach was not tortuous.The product was stored and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 returned for analysis.Patient information was requested but was not available.

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.The device analysis remains pending.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

There was difficulty when advancing the optease retrievable filter 55 and it punctured the sheath during delivery of the filter.The filter was withdrawn and replaced with another one to complete the procedure.The patient was not morbidly obese and the approach was not tortuous.The product was stored and handled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 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 returned for analysis.Per visual analysis, the obturator was already inserted on the sheath.A perforated condition was found on the cannula sheath by the filter barbs.No other anomalies were found along the device.No other component was returned for analysis.A functional analysis was not performed.Per microscopic analysis, amplified images were taken to a better observation of the perforated sheath.The type of damage present on the cannula is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage, it seems the cannula material was punctured with a sharp object from the inside of the cannula, in this case the barbs of the filter, that could probably led to the perforated condition found on the received component.Additionally, the filter was viewed under the vision system, with special attention given to the barbs and no anomalies were found.A product history record (phr) review of lot 17881976 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿filter ¿ impeded - perforated sheath¿ was confirmed since a perforated condition was found on the cannula during visual analysis.However, the exact cause of this condition could not be conclusively determined during the analysis.Procedural and/or handling factors, such as operator technique, might have contributed to the reported event since the device did not present any obvious indication of manufacturing defect or anomaly.According to the 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 review nor the product analysis suggests that the reported event could be related to the design or manufacturing process of the unit; therefore, no corrective or preventive actions will be taken.

• 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: 11088070
• MDR Text Key: 224521402
• Report Number: 9616099-2020-04156
• 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: 01/22/2021

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17881976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1