MAUDE Adverse Event Report: CORDIS DE MEXICO OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F210A

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17527560) presented no issues during the manufacturing process that can be related to the reported event.  this device has been received for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.

Event Description

It was reported that during a lower extremity venous catheter surgery, the filter was released and was found to be inverted.The surgeon had to recover the filter from the neck.The filter was removed via the catheter.The procedure made an approach from the femoral vein.

Manufacturer Narrative

Corrected data:  pma/510(k)number.It was reported that during a lower extremity venous catheter surgery, the filter was released and was found to be inverted.The procedure was performed via approach from the femoral vein.The surgeon had to recover the filter from the neck.The filter was removed via the catheter.The procedure made an approach from the femoral vein.Upon return for analysis, the device was noted to be un-deployed and remained in the storage tube.Additional follow up with the customer noted that the physician could not confirm the original event description reported but confirmed that the correct device was returned for analysis.The product was returned for analysis.A non-sterile optease retr filter 55 was received inside a plastic bag containing only the storage tube with the filter inside.Per visual inspection no damages were observed at the storage tube body.Filter was inside of the storage tube at the correct orientation.Filter never was out loaded of it storage tube.A device history record (dhr) review of lot 17527560 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter-inaccurate placement/upside down¿, could not be confirmed through analysis of the returned device as the filter was still loaded in storage tube un-deployed.The customer has confirmed that the correct device was returned.The exact root cause could not be determined.As per the instructions for use (ifu), ¿according to the selected venous access site, determine which end of the storage tube (containing the filter) is to be placed into the sheath introducer hemostasis valve.This is indicated by the printed colored arrows and text on the storage tube.The arrow of the desired access site will point into the sheath introducer hemostasis valve.Place the appropriate end of the storage tube (containing the optease retrievable filter), as far as possible into sheath introducer hemostasis valve.Slowly advance the filter into the sheath introducer by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.To release the filter, keep the obturator fixed in position, then pull the sheath introducer back over the obturator.¿ neither the dhr nor the analysis of the returned device suggest design or manufacturing cause for the event; therefore no corrective action will be taken.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 6595322
• MDR Text Key: 76091464
• Report Number: 9616099-2017-01128
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023116
• 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
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 466F210A
• Device Lot Number: 17527560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2017
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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
• Patient Outcome(s): Required Intervention