• 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 FEMORAL 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 FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220AF
Device Problems Catheter (3038); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2020
Event Type  Malfunction  
Manufacturer Narrative

During insertion of a 55 optease retrieval filter with a dilator and sheath introducer into the patient, the tip of the sheath introducer of got split. Therefore, the physician did not use the device to avoid any risks that it would be implanted improperly. There was no issue confirmed with the optease filter. The procedure was completed using a non-cordis device and hemostasis was achieved. There was no reported patient injury. The indication for filter insertion was for deep vein thrombosis (dvt). The dvt documented was diagnosed thru the femoral artery. The device was stored and handled per the instructions for use (ifu). The device was prepped according to the ifu. There were no damages noted to the packaging to the device prior to use. The device was removed from its packaging as per the ifu. The product was not returned for analysis. A product history record (phr) review of lot 17666027 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿brite tip/distal tip (optease) frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics or patient characteristics, although unknown, may have contributed to the reported event. According to the safety information in the instructions for use ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. Caution: to avoid damage to the sheath introducer tip, do not withdraw the dilator until the sheath introducer tip is at the desired location in the ivc. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

 
Event Description

During insertion of a 55 optease retrieval filter with a dilator and sheath introducer into the patient, the tip of the sheath introducer of got split. Therefore, the physician did not use the device to avoid any risks that it would be implanted improperly. There was no issue confirmed with the optease filter. The procedure was completed using a non-cordis device and hemostasis was achieved. There was no reported patient injury. The indication for filter insertion was for deep vein thrombosis (dvt). The dvt documented was diagnosed thru the femoral artery. The device was stored and handled per the instructions for use (ifu). The device was prepped according to the ifu. There were no damages noted to the packaging to the device prior to use. The device was removed from its packaging as per the ifu. The device will not be returned for evaluation as it was discarded due to infectious disease.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTEASE RETR FILTER 55 FEMORAL
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 Key9969452
MDR Text Key200259702
Report Number9616099-2020-03650
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL Number466F220AF
Device Catalogue Number466F220AF
Device LOT Number17666027
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/26/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-