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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 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, the 55 optease retrievable filter was pushed into the ¿delivery rod¿ and cannot be released. The malfunction occurred during use. There was no reported patient injury. The filter was placed post cava, for pulmonary embolism (pe) prevention. The lesion had no calcification, no vessel tortuosity, no angulation, and no stenosis. The device was stored and handled according to the instructions for use (ifu). There were no visible signs of device/package damage prior to use. The device was prepped per the ifu and prepped normally. There were no kinks or other damages noted prior to inserting the product into the patient. The insertion difficulty was not caused by a blockage of possibly injectable material. There was no unusual force used at any time during the procedure. The malfunction required that all the concomitant products be removed together. The device was easily removed from the patient intact (in one piece). As per product analysis, a filter barb was observed piercing the cannula from the inside, preventing the filter to deploy. Nevertheless, functional test was performed successfully; the filter was deployed successfully. A puncture/hole was observed on the cannula once the filter was deployed. Per microscopic analysis of the puncture/hole observed on the cannula, sem results showed that the inner surface of the cannula presented scratch marks and bulged/peeled off material near the puncture/hole. This type of damage is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage. It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the cannula surfaces could probably led to the punctured condition found on the received cannula. It seems the cannula material was punctured with a sharp object from the inside of the cannula. The cause of the filter barb piercing the cannula could not be conclusively determined during the analysis. The filter was revised under vision system, especial attention was given to the barbs, but no anomalies were found. The device will be returned for evaluation.
 
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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 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key11300414
MDR Text Key232380378
Report Number9616099-2021-04248
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
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 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466F210A
Device Catalogue Number466F210A
Device Lot Number17939408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2020
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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