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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Model Number N/A
Device Problems Filter (816); Therapy Delivered to Incorrect Body Area (1508); Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). The product is not available for evaluation and testing. Additional information will be submitted within 30 days of receipt.

 
Event Description

During the use of an optease retrievable filter, it was reported that placing the filter was reversed. The hook is facing jugular, it is removed by surgery. Additionally, it was reported that the medical device filter came packaged incorrectly. There was no report of patient injury. The product is not available for analysis. The patient did not present any symptoms, during the control the physician saw the filter was moved. After removal of the filter, the patient did not show any symptoms. The patient is very well and has started his normal activities. It was noted that the filter could not be removed by the jugular, the filter stay invested. The vena cava was approximately 25mm (below the renal). The physician has used the optease filters on 15 occasions. Procedural films are available. Pre/post imaging was completed.

 
Manufacturer Narrative

Additional information received confirmed that the same physician that implanted the optease was the one that removed the optease. The device was removed on (b)(6) 2016. No pictures are available. Complaint conclusion: as reported, an optease retrievable filter was ¿packaged incorrectly and was placed with the hook ¿facing jugular¿. The filter was ¿removed by surgery. ¿ the vena cava was approximately 25mm (below the renal). The optease filter was implanted on (b)(6) 2016 and the hook was noted to be ¿facing jugular. ¿ the patient was asymptomatic and the reporter noted that ¿during the control the physician saw the filter was moved. ¿ the filter could not be removed jugularly and remained implanted until it was removed surgically by the same physician on (b)(6) 2016. The patient was asymptomatic after removal of the filter and has reportedly resumed normal activities. The product was not returned for analysis, nor were pictures of the filter storage tube or procedural films provided. A review of the manufacturing documentation associated with this lot # 17281864 was performed and revealed no anomalies during the manufacturing and inspection processes. The reported ¿filter ¿ inaccurate placement upside down¿ could not be confirmed as procedural films were not provided for review. Additionally, the reported ¿storage tube ¿ labeling incorrect¿ could not be confirmed as the device was not returned for analysis nor were pictures provided for review. The root cause and clinical factors contributing to the difficulty experienced by the customer could not be conclusively determined. The instructions for use instructs, ¿according to the selected venous access site, determine which end of the storage tube (containing the filter) is to be placed into the sheath introducer hemostasis valve. This is indicated by the printed colored arrows and text (femoral: green; jugular/ antecubital: blue) on the storage tube. The arrow of the desired access site will point into the sheath introducer hemostasis valve. Place the appropriate end of the storage tube (containing the opteaser retrievable filter), as far as possible into sheath introducer hemostasis valve. Slowly advance the filter into the sheath introducer by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer. ¿ based on the information available for review and the dhr, a correlation between the event and the design and manufacturing process could not be confirmed; therefore, no corrective action will be taken at this time.

 
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Brand NameOPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
arca 345705 colombia
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5496049
MDR Text Key40200901
Report Number9616099-2016-00129
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK023116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device MODEL NumberN/A
Device Catalogue Number466F210A
Device LOT Number17281864
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 Received04/07/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/17/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/11/2016 Patient Sequence Number: 1
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