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

Model Number 466F220AF

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17805598 presented no issues during the manufacturing process that can be related to the reported event.The device was not returned for analysis.A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a sheath and the dilator of an optease were attempted to be inserted, however the distal end of the sheath became frayed.There was no reported patient injury.Therefore it was replaced with a new optease and it could be inserted.An approach was made from the femoral artery.The device will not be returned for analysis because of an emergent procedure.

Manufacturer Narrative

As reported, a sheath and the dilator of an optease inferior vena cava filter were attempted to be inserted, however the distal end of the sheath became frayed.There was no reported patient injury.Therefore it was replaced with a new optease and it could be inserted.An approach was made from the femoral artery.The device will not be returned for analysis because of an emergent procedure.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without the return of the product for analysis, the event reported by the customer as ¿brite tip (csi/filters)- frayed/split/torn¿ could not be confirmed.Procedural factors, (such as interaction of the cannula sheath with a concomitant vessel dilator or guide wire) may contribute to the failure as reported.According to the instructions for use (ifu), ¿a vessel dilator facilitates the percutaneous entry of the csi by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative 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, co. tipperary; EI
• MDR Report Key: 8340302
• MDR Text Key: 136170060
• Report Number: 9616099-2019-02709
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 466F220AF
• Device Catalogue Number: 466F220AF
• Device Lot Number: 17805598
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1