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

Catalog Number 466F220AJ

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

During an interventional endovascular procedure for placement of a 55 cm.Optease retr.Inferior vena cava (ivc) filter jugular, the physician attempted insertion of the sheath but the distal end of the sheath became frayed.Therefore, the product was replaced with another optease filter and it was inserted from the femoral approach without any issue.There was no reported patient injury.

Manufacturer Narrative

During an interventional endovascular procedure for placement of a 55 cm.Optease retrievable inferior vena cava (ivc) filter jugular, the physician attempted insertion of the sheath but the distal end of the sheath became frayed.Therefore, the product was replaced with another optease filter and it was inserted from the femoral approach without any issue.There was no reported patient injury.The product was not returned for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.However, patient and procedural factors may have contributed to the insertion difficulty and subsequent sheath fraying.Without the return of the devices for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made according to the instructions for use (ifu), if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.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 JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7703021
• MDR Text Key: 114558618
• Report Number: 9616099-2018-02258
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• 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: 466F220AJ
• Device Lot Number: 17539623
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1