• 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 THROMBECTOMY SYSTEMS

  • 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 THROMBECTOMY SYSTEMS Back to Search Results
Model Number N/A
Device Problems Material Frayed (1262); Catheter (3038); Tip (3123); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). The device was not returned for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During insertion of the sheath within an optease retrieval filter kit, the distal end of the sheath became frayed. Therefore, it was replaced with a new optease and it could be inserted. There was no reported patient injury. The device will not be returned for analysis because of an emergent procedure. An approach was made from the femoral artery. The product appeared normal when taken from its packaging. There was no difficulty flushing or assembling the devices. The access site was not a chronic total occlusion (cto) and did not have any stenosis. There was no excessive force used to insert the sheath. A dilator was used prior to inserting the sheath. The product appeared normal when taken from its packaging. There was no difficulty flushing or assembling the devices. The access site was not a chronic total occlusion (cto) and did not have any stenosis. There was no excessive force used to insert the sheath. A dilator was used prior to inserting the sheath.

 
Manufacturer Narrative

During insertion of the sheath within an optease retrieval filter kit, the distal end of the sheath became frayed. Therefore, it was replaced with a new optease and it could be inserted. There was no reported patient injury. The device will not be returned for analysis because of an emergent procedure. An approach was made from the femoral artery. The product appeared normal when taken from its packaging. There was no difficulty flushing or assembling the devices. The access site was not a chronic total occlusion (cto) and did not have any stenosis. There was no excessive force used to insert the sheath. A dilator was used prior to inserting the sheath. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTEASE RETR FILTER 55 FEMORAL
Type of DeviceTHROMBECTOMY SYSTEMS
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8037464
MDR Text Key127888232
Report Number9616099-2018-02489
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/05/2018
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 NumberN/A
Device Catalogue Number466F220AF
Device LOT Number17666027
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-