MAUDE Adverse Event Report: CORDIS DE MEXICO OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466F210A

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2011

Event Type  Injury  

Event Description

The report received from the affiliate indicated that during a review of optease retrievable filter patients for the medical device authority (mda) for this issue, a patient was identified with definite wrong orientation of the filter not thought to be due to operator error.The event is being presumed to be due to a labeling error as per mda.The patient status is that the patient is alive with no complications reported.The report indicated that the patient is being recalled for further imaging and counseling by the medical team as per the mda.Additional information has been requested.

Manufacturer Narrative

Please note that the date of implantation is being reported as (b)(6) 2011 as the exact date of implantation was not provided.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: a patient was identified with incorrect orientation of the filter that was thought to be related to a labelling error per the user.The device is in vivo and there are no reported patient complications.The patient is being asked to return for further imaging and counselling by medical team.Multiple attempts have been made to gather additional information.However, no additional information regarding patient, lesion or procedural characteristics regarding this event has been provided.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Since the product or films of the procedure will not be returned, there is not enough information to draw a clinical conclusion between the device and the event.The product was not returned for analysis.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.

• Brand Name: OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4009104
• MDR Text Key: 4707242
• Report Number: 9616099-2014-00524
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 466F210A
• Device Lot Number: 15109705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention