MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466F220A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that the device will be returned but subsequent information indicates the physician decided to leave the device implanted.Therefore, it is not available for return.Additional information is pending and will be returned for analysis.

Event Description

The report received from the affiliate indicated that an optease filter did not open to its full size (only to 55% to 60% of its size).The filter was removed to avoid possible migration and or clots to go through.The device will be returned for analysis.The physician decided to leave it implanted within the patient due to the patient's age.

Manufacturer Narrative

Additional information was received that the patient is doing fine.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The report received indicated that an optease filter did not open to its full size (only to 55% to 60% of its size).The filter was removed to avoid possible migration and or clots to go through.Subsequent information was later received which noted that the physician decided to leave the device implanted within the patient due to the patient¿s age.The patient was reported to be doing fine.A review of the manufacturing documentation associated with lot 17199554 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported incomplete expansion of the filter could not be confirmed as the device was not returned (it remained implanted in the patient) nor were procedural films provided for review.The exact cause could not be determined.Given the limited information available for review, factors contributing (vessel characteristics, procedural factors) to the reported issue could not be determined.Neither the dhr nor the information available for review suggests a design or manufacturing related cause for the difficulty experienced by the customer; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17199554 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5814434
• MDR Text Key: 50188585
• Report Number: 9616099-2016-00453
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 466F220A
• Device Lot Number: 17199554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 45