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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL THROMBECTOMY SYSTEMS

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CORDIS CASHEL OPTEASE RETR FILTER 55 FEMORAL THROMBECTOMY SYSTEMS Back to Search Results
Model Number N/A
Device Problems Material Frayed (1262); Catheter (3038); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis cashel are respectively, (b)(6). The device was returned but the engineering report is pending. 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

An optease vena cava filter was attempted to be inserted but the distal end marker of its sheath was frayed and turned towards out. Therefore, it was replaced with a new product to continue the procedure. There was no patient injury and the device will be returned for analysis.

 
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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 CORPORATION
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7826969
MDR Text Key118576286
Report Number9616099-2018-02351
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 09/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number466F220AF
Device LOT Number17755556
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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