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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETR FILTER 55 FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION OPTEASE RETR FILTER 55 FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F210AF
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but has not yet been received. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

When the operator pushed the 55cm femoral optease retrievable vena cava into the non-cordis sheath, it was found that the sheath was cracked when pushing the filter into the sheath and the optease could not be delivered to the patient¿s body. It was then replaced with a new unknown filter and sheath to complete the procedure. There was no reported patient injury. The operator was trained to use the device. The indication for filter insertion was to prevent dvt/pe. The device was prepped per the instructions for use (ifu). There was no difficulty experienced in prepping the device. The device did not kink nor bend at any time. The other devices used with the product did not kink nor bend at any time. The product, or any of the other devices used with it, had been resterilized. The insertion difficulty was not caused by a blockage of possibly injectable material. The device will be returned for evaluation.

 
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Brand NameOPTEASE RETR FILTER 55 FEMORAL
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12098908
MDR Text Key259423928
Report Number9616099-2021-04672
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F210AF
Device Catalogue Number466F210AF
Device LOT Number17955288
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/01/2021 Patient Sequence Number: 1
Treatment
TERUMO SHEATH
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