MAUDE Adverse Event Report: CORDIS DE MEXICO OPTEASE RETR FILTER 55 JUGULAR; VENA CAVA FILTER

Model Number N/A

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is available for analysis but has not yet been received.  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

During an interventional procedure an optease jugular filter was caught when inserted into the obturator and the sheath frayed at 20 cm from its distal tip.It was unknown how the procedure completed but it was finished successfully.There was no reported patient injury.The product will be returned for analysis.  the lesion was heavily tortuous.The rate of stenosis was unknown.An approach was made from the left femoral vein.Then an optease was inserted. the product was stored, handled, inspected and prepped according to the instructions for use.  there was nothing unusual noted about the device prior to use.  additional procedural details were requested but are unknown. .

Manufacturer Narrative

The device was returned and device available for evaluation was updated accordingly.   the completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

During an interventional procedure an optease jugular filter was caught when inserted into the obturator and the sheath frayed at 20 cm from its distal tip.It was unknown how the procedure completed but it was finished successfully.There was no reported patient injury.The lesion was heavily tortuous.The rate of stenosis was unknown.An approach was made from the left femoral vein.Then an optease was inserted.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the device prior to use.Additional procedural details were requested but are unknown.The product was returned for analysis.A non-sterile optease retrieval filter 55 jugular filter caught inside a cannula sheath along with two obturators were returned for analysis.Per visual analysis, one of the obturators was kinked at 32.5 cm, at 35.5 cm and at 36.5 cm from the hub.Also, the cannula sheath was kinked at 31.5 cm and at 35.2 cm from the hub.No other anomalies were noted.Per dimensional analysis the cannula sheath and obturator od and id were measured near to the kinked areas and were found within specification.Per functional analysis the filter was advanced through the csi cannula sheath.The non-kinked obturator was used to push the filter through the cannula sheath all the way out.The filter was successfully advanced all along through the cannula sheath despite kinks on cannula.Per microscopic analysis, the filter and filter barbs were inspected under vision system and no anomalies were observed.(see attached pictures).A device history record (dhr) review of lot 17488373 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter ¿ impeded¿, ¿catheter sheath introducer (csi)-obstructed¿ and ¿brite tip (csi/filters)-frayed/split/torn¿ were not confirmed through analysis of the returned devices.The exact cause of the reported events could not be determined during analysis.Based on the information available for review, vessel characteristics (heavy tortuosity) may have contributed to the events as evidenced by kinks noted on the obturator and cannula during analysis.According to the instructions for use ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.It is the responsibility of the physician to use his/her judgement, based on patient safety and clinical experience, regarding the acceptability level of any resistance and/or whether to continue or abort the retrieval attempt.¿ neither the dhr review, the procedure films nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.(b)(4).

• Brand Name: OPTEASE RETR FILTER 55 JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6533709
• MDR Text Key: 74123246
• Report Number: 9616099-2017-01060
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 466F220AJ
• Device Lot Number: 17488373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/06/2017
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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