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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Catalog Number 466F220AJ
Device Problems Crack (1135); Catheter (3038); Tip (3123)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). Complaint conclusion: as reported, a crack on the distal tip of the included brite tip sheath was confirmed after an optease was taken out of its pouch. There was no reported patient injury. The product was not clinically used. The target lesion was unknown. The lesion was not calcified and not tortuous. The rate of stenosis was unknown. There were no other damages or anomalies noted to the device or packaging. The device was stored and handled according to the instructions for use (ifu) with no difficulty removing the devices from the packaging. It is unknown if this issue was noted immediately after removal from packaging. It is unknown what was done to complete the procedure. The device was not returned for analysis. Review of lot 17259785 revealed no anomalies during the manufacturing and inspection processes no units were rejected during the final assembly of this lot. No other issues were noted that were considered potentially related to the reported complaint. The reported distal tip crack of the csi could not be confirmed and the root cause could not be determined as the device was not returned for analysis. Giving the information available for review, clinical factors contributing to the event could not be conclusively determined; however, it is possible that handling factors may have contributed to the reported event. Neither the information available nor the dhr suggests a design of manufacturing related cause for the reported event; therefore, no corrective action will be taken at this time.

 
Event Description

As reported, a crack on the distal tip of the included brite tip sheath was confirmed after an optease was taken out of its pouch. There was no reported patient injury. The product was not clinically used. And it will not be returned for analysis. The patient was a (b)(6) female. The target lesion was unknown. The lesion was not calcified and not tortuous. The rate of stenosis was unknown. There were no other damages or anomalies noted to the device or packaging. The device was stored and handled according to the instructions for use (ifu) with no difficulty removing the devices from the packaging. It is unknown if this issue was noted immediately after removal from packaging. It is unknown what was done to complete the procedure.

 
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Brand NameOPTEASE VENA CAVA FILTER
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5880083
MDR Text Key52291090
Report Number9616099-2016-00511
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device Catalogue Number466F220AJ
Device LOT Number17269135
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 Received07/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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