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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION OPTEASE RETR FILTER 55 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F210A
Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
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. A file with one picture was received for picture analysis related to complaint case-(b)(4). Per picture analysis, an optease retr filter 55 cannula unit was observed perforated by a filter barb, from the inside to the outside of the cannula. No other anomalies were observed. It is unknown if the device will be returned for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During implantation of a 55cm optease retrievable vena cava filter, the operator found that the barb of the optease was inserted into the side wall of the release sheath which made impossible to continue pushing. Therefore, the operator stopped the release of the filter. There was no reported patient injury. The user was trained with the device. The device will be returned for evaluation. Device image is available for review.

 
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Brand NameOPTEASE RETR FILTER 55
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 Key12223494
MDR Text Key263385614
Report Number9616099-2021-04730
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
Report Date 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466F210A
Device Catalogue Number466F210A
Device LOT Number17984910
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2020
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: 07/26/2021 Patient Sequence Number: 1
Treatment
UNK.
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