MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220AF

Device Problems Partial Blockage (1065); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

During use, it was reported that the optease filter will not advance completely through the catheter sheath introducer.After the picture was reviewed, it was noted that the filter barb appears to have perforated the cannula.Both devices were removed the patient and a new unknown product was used to complete the procedure.An optease was inserted, however, during delivery, it stuck in the sheath and could not advance more.The device will be returned for analysis and a picture is attached.

Manufacturer Narrative

During use, it was reported that the optease filter would not advance completely through the catheter sheath introducer (csi).The optease filter was inserted, however, during delivery it stuck in the sheath and could not advance more.Both devices were removed the patient and a new optease product was used to complete the procedure.There were no problems noted during prepping.Insertion difficulty caused by a blockage of possibly injectable material.The target lesion was the inferior vena cava which was not calcified, tortuous and no stenosis.The device will be returned for analysis and a picture is attached.The product was stored as usual for two months.No other information was provided.One picture is received of a sheath introducer that appears to have a filter in it.The sheath seems to be punctured with a sharp object, possibly a filter barb.Per analysis of returned device: one non sterile 6f sheath introducer was received inside a plastic bag along with its obturator and the filter storage tube.Per visual analysis.It was noticed that the optease filter was received inserted though the sheath introducer unit and the barb of the filter was protruding the cannula body at 10.4cm from distal end.No kinks or bent conditions were found near the protruding condition.No anomalies/damages were found neither on the received obturator nor on the filter storage tube.The filter was retrieved from sheath introducer cannula and reloaded to the filter storage tube.The received storage tube with filter was placed into the hub of the received 6f sheath introducer and the obturator was inserted into the filter storage tube.The obturator was pushed and the filter was able to be advanced through the sheath introducer with no resistance/friction felt.A device history record (dhr) review of lot 17586637 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿filter impeded - perforated sheath¿ was confirmed due to the condition of the product as it was received for analysis.The complaint reported by the customer as ¿cannula (csi/filters) - obstructed - in patient¿ was not confirmed, since during the functional analysis no obstruction or resistance/friction was felt.The root cause of the event reported by the customer could not be conclusively determined during the analysis, nonetheless the obstruction reported could be related to the (filter impeded, perforated sheath) condition of received product.However, the cause of perforated sheath could not be conclusively determined during product analysis.It is possible that handling or procedural factors may have contributed to the difficulty experienced by the customer.When the filter is passing an acute bend inside the sheath due to vessel tortuosity or if force is applied, the barbs have the potential to perforate the sheath.The ifu instructs ¿to slowly advance the filter into the sheath introduce by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.If the filter advancement is problematic, advance the sheath introducer to negotiate the curve, and then continue to advance the filter.If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding¿.Neither product analysis nor phr review results suggest that these damages found could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7393942
• MDR Text Key: 104431708
• Report Number: 9616099-2018-02040
• 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
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17586637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Distributor Facility Aware Date: 03/05/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1