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

Model Number 466F220AF

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Additional information was received and the device was received with a cut/separated at 35.5cm from cannula hub.It was reported that the optease filter with its sheath introducer got kinked.Therefore the devices were replaced with a new 7f non cordis product and the procedure was completed successfully.There was no reported patient injury.This was a filter embolization case and an approach was made from the femoral vein.The target lesion was the inferior vena cava.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The products were prepped according to the instruction for use (ifu).There were no difficulty noted during prep.There any damages noted to the device packaging.The product was clinically used and will be returned for analysis.

Manufacturer Narrative

It was reported that the sheath introducer of the optease filter got kinked.Therefore the device was replaced with a new 7f non cordis product and the procedure was completed successfully.There was no reported patient injury.This was a filter embolization case and an approach was made from the femoral vein.The target lesion was the inferior vena cava.The patient¿s vessel level of tortuosity and calcification are unknown.The rate of stenosis is unknown.The products were prepped according to the instruction for use (ifu).There was no difficulty noted during prep.There were not any damages noted to the device packaging.The product was clinically used and will be returned for analysis.A non-sterile optease retrievable filter was received inserted through the sheath introducer cannula along with the storage tube and the obturator.Per visual analysis, the catheter sheath introducer was received separated at 35.5cm from cannula hub (the distal section was not received for analysis).No anomalies or damages were found on the received obturator, the storage tube or on the filter.The cannula was inspected under microscope and the characteristics observed suggested cutting conditions.The received cannula was sent to sem analysis to confirm the cut characteristics observed on the received cannula.Sem analysis concluded that the separated section of the cannula showed evidence of elongations and partial cutting conditions, the pattern observed on the transversal section suggests that a sharp object induced the separation observed.No other anomalies were found during sem analysis.A device history record (dhr) review of lot 17594357 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer ¿catheter sheath introducer (csi) - kinked/bent¿ was not confirmed since no kinked conditions were found on the received unit.Instead of a kinked condition, a cut /separated condition was found on the received cannula.The cause of the ¿cannula (csi/filters) ¿separated¿ could not be conclusively determined during the analysis.The pattern observed on the transversal section suggests that a sharp object induced the separation observed.Handling or procedural process may have contributed to the separated condition found.The instructions for use cautions users to inspect for anomalies in the product, or other signs of damage prior to and during use.Any product with damage is not to be used.Neither the dhr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.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 32575 ; EI 32575
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6891658
• MDR Text Key: 87646910
• Report Number: 9616099-2017-01453
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17594357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/31/2017
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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