• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CASHEL OPTEASE RETR FILTER 55 JUGULAR FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTEASE RETR FILTER 55 JUGULAR
Type of DeviceFILTER, 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 Key8607371
MDR Text Key145028068
Report Number9616099-2019-02929
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK034050
Number of Events Reported1
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 Received05/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device MODEL Number466F220AJ
Device Catalogue Number466F220AJ
Device LOT Number17556193
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-