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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL CATHETER THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION OPTEASE RETRIEVAL CATHETER THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Model Number N/A
Device Problems Shaft (955); Difficult to Remove (1528); Defective Component (2292); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2016
Event Type  Injury  
Manufacturer Narrative

(b)(6). (b)(4). Complaint conclusion: during the retrieval of an optease, it was reported that ¿the tip has been seen like swallowed inside of the catheter. The filter was snared and the retrieval catheter. ¿ there was no separation of the device. According to the physician, it was ¿a straightforward¿ procedure. There was no report of patient injury. There was no difficulty/resistance actuating the product. The filter had been placed in the vena cava. There was ¿nothing special¿ on the characteristics of the vessel. The device was returned for analysis. A non-sterile 10fr optease retrieval cath was received for analysis coiled inside a plastic bag. Per visual analysis, the catheter distal tip was observed kinked/ prolapsed. Also, several kinks were observed on the body shaft of catheter. The catheter distal tip od and id as well as the body shaft od and id measured at different sections and results were found within specification (except for the distal tip measure out of specification most probably due to kinked/damaged condition as received). Review of lot 17402403 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The reported ¿catheter body/shaft - withdrawal difficulty¿ was not confirmed due to the nature of complaint and procedural factors (vessel characteristics/handling factor) could not be replicated. Additionally, the outer diameter of the catheter was measured and found within specification with the exception of the kinked locations. The reported ¿brite tip/distal tip - prolapse¿ was confirmed due to the kinked/ prolapsed condition of unit as received. Based on the limited information available for review, factors contributing to the difficulty experienced could not be conclusively determined. It is possible that patient factors, such as vessel tortuosity, may have contributed to this issue. Neither the dhr review nor the product analysis suggests that the kinked/prolapsed conditions and withdrawal difficulty are related to the manufacturing process; therefore, no corrective action will be taken at this time.

 
Event Description

During the retrieval of an optease, it was reported that "the tip has been seen like swallowed inside of the catheter". The filter was snared and the retrieval catheter. According to the physician it was a straightforward procedure. There was no report of patient injury. The device will be returned for analysis. There was no difficulty/resistance actuating the product. The filter had been placed in the vena cava. There was "nothing special" on the characteristics of the vessel. The account further clarified that there was no separation of the catheter.

 
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Brand NameOPTEASE RETRIEVAL CATHETER
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 Key5660739
MDR Text Key45333061
Report Number9616099-2016-00245
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device MODEL NumberN/A
Device Catalogue Number466C210F
Device LOT Number17402403
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/02/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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