MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE RETREIVAL CATHETER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

The lot number of the device provided is not a lot number for a thrombectomy device.Clarification has been requested and is still pending.Additional details of the reported event have also been requested including the return of the device which has not yet been received.Additional information received will be submitted within 30 days upon receipt.

Event Description

During retrieval of an optease filter that was implanted in the previous month, a 7f ensnare inserted into the optease retrieval catheter was not adequate to retrieve the filter and the filter was released back into the inferior vena cava.The catheter was left in and exchanged for a 6fr ensnare.It was noted by physician and scrub nurse that there was an object floating around the caudal hook of the filter.This was noticed under fluoroscopy.The 6fr ensnare was inserted and snared onto the caudal hook and collapsed the filter within the sheath.The doctor did a fluoroscopy to locate the floating radiopaque object but nothing as found.Once the case completed and equipment removed from patient, it was noted that the yellow radiopaque tip marker was not present on the optease retrievable catheter.The physician and staff compared the tip with another optease retrievable catheter that was on shelf.The patient went back to recovery with no complications.The item is available for collection.The patient had the ivc filter inserted in july of this year.This was for a retrieval of the optease filter.Femoral access was obtained with no complications.Optease retrievable catheter was opened by scrub nurse and it was within date.Preparation as per ifu.Doctor has used this product numerous of times and is very familiar with the retrieval catheter.Medical sales representative was not present of time of the incident.A 10fr sheath optease retrievable catheter was inserted femoral.A 7fr ensnare was opened and inserted through the retrievable catheter.When physician tried to snare the caudal hook of the filter and filter was pulled back 2-3 cm within the sheath.No resistance was felt by the physician.

Manufacturer Narrative

The device was returned.The device had a kink at 29.5 from the distal end.The completed engineering report and any further additional details received will be submitted within 30 days upon receipt.

Manufacturer Narrative

During retrieval of an optease filter, which had been implanted within the previous month, a 7f ensnare was inserted into the optease retrieval catheter, the ensare was not adequate to retrieve the filter.The filter was released back into the inferior vena cava.The catheter was left in and exchanged for a 6f ensnare.Under fluoroscopy, it was noted that there appeared to be an object floating around the caudal hook of the filter.The 6fr ensnare was inserted and snared onto the caudal hook and collapsed the filter within the sheath.An angiographic picture was performed to locate the floating radiopaque object but nothing was found.After completion of the case, the tip of the used retrievable catheter was compared with the tip of an unused optease retrievable catheter.It was noted that the yellow radiopaque tip marker was not present on the optease retrievable catheter.No patient injury was noted.Femoral access was obtained with no complications.The optease retrievable catheter was prepped as per instructions for use (ifu).The performing doctor has used this product numerous of times and is very familiar with the retrieval catheter.A 10fr sheath optease retrievable catheter was inserted femoral.When physician tried to snare the caudal hook of the filter and filter was pulled back 2-3 cm within the sheath.No resistance was felt by the physician.There was no force used during the procedure.No further patient injury was noted while in recovery.One non-sterile unit of a sheath retrievable catheter was received for analysis coiled inside a plastic bag.The mentioned concomitant filter complaint was not returned.Per visual analysis, the tip of the retrievable catheter was observed separated (missing/ not returned for analysis).The tip separation area was inspected under vision system and inspection results showed evidence of plastic deformation and elongations at the separation edge; elongation is a common characteristic of pieces which were stretched / pulled until separation by an excessive application of a tension force that induced the separation.These conditions were also observed on the ptfe inner member of unit, no other anomalies found.The product history review could not be performed due to the lot number provided is not recognized in the jde system as the description of the product in the complaint.The reported event by the customer as ¿brite tip/distal tip- separated - in patient¿ as well as the reported event by the customer as ¿filter-retrieval difficulty - unable to pull into retrieval catheter/gc¿ were confirmed due to the separated condition of the tip of the unit received.However, the exact cause of the tip separated condition found on the catheter could not be conclusively determined during the analysis.Based on the information available for review, procedural or handling factors may have contributed to the separation as evidenced by elongations noted on the separated edge during analysis which are indicative of excessive force being applied to the device.The implantation date of the filter and the attempted retrieval date is unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The ifu also notes: ensure that the loop of the snare has properly engaged the retrieval hook and that the retrieval hook, retrieval catheter and snare are aligned (figure 10a illustrates correctly aligned, figure 10b illustrates incorrectly aligned).The marker tip of the snare catheter must be caudal to the filter hook.There must be a clear distance between the marker tip of the endovascular snare catheter and the denser end of the filter apex.The performed product analysis does not suggest that the events reported by the customer could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: UNKNOWN OPTEASE RETREIVAL CATHETER
• Type of Device: OPTEASE RETREIVAL CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6844584
• MDR Text Key: 84960113
• Report Number: 9616099-2017-01391
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Device Lot Number: 17659973
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/16/2017
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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
• Treatment: 7FR ENSNARE6FR SNARE
• Patient Outcome(s): Life Threatening; Required Intervention