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

Model Number 466F220AJ

Device Problems Material Frayed (1262); Catheter (3038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

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, an optease sheath was attempted to be inserted, however the marker was scratch (frayed). There was no patient injury. Therefore the optease was replaced with a new device and the procedure was completed. The target lesion was not tortuous, calcified, or stenosed. The product stored, handled, inspected and prepped according to the instructions for use (ifu) with no unusual or damages noted about the delivery sheath prior to use. The device package was not damaged. Excessive force was not used when the device was removed from the packaging. There was no excessive force used during the procedure. The doctor requested a customer letter. The device is available for analysis. No other information was provided.

• Brand Name: OPTEASE RETR FILTER 55 JUGULAR
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8607371
• MDR Text Key: 145028068
• Report Number: 9616099-2019-02929
• 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: FOREIGN

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/14/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/31/2019
• Device MODEL Number: 466F220AJ
• Device Catalogue Number: 466F220AJ
• Device LOT Number: 17556193
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/10/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial