• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 466F210A
Device Problems Filter (816); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Cannula Guide (3037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. A review of the manufacturing documentation associated with lot 17891908 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was a resistance felt when a 55cm optease retrievable filter was pushed one third into the delivery sheath with the use of a solid push rod. Therefore, the solid push rod together with the sheath were completely removed from the patient and it was found that the rod had the filter sticking out of the sheath and it could not be pushed with the solid rod. The physician cut the sheath in the middle to completely removed the filter and the parts were complete. Picture analysis states that the cannula was observed to have a separated condition. Manual compression at the femoral vein was done and a new approach was made from the jugular vein using a new cordis filter. The device was implanted, and the operation was completed smoothly according to the steps and the patient returned to the ward after the operation. The patient recovered after the event. There was no reported patient injury. The device was intended to be used for a patient with pulmonary embolism. The device was stored and handled as per the instruction for use (ifu). There were no damages noted to the packaging of the device prior to use. The device was prepped according to the ifu. Pulmonary embolism (pe) or deep vein thrombosis (dvt) was diagnosed using an angiographic examination. The extent of the dvt was moderate. Venous transfusion and oral medications were used as an anticoagulation therapy. There was no contraindication for anticoagulation. Pre and post imaging were completed. The size was estimated, and shape of the vena cava was fusiform where a cordis filter was implanted. After phlebography was done at the femoral vein and iliac vein. No thrombus was found at the inferior vena cava. A 5f non-cordis sheath was inserted followed by a 0. 035¿ 180cm unknown guidewire and the 5f non-cordis sheath was removed. The guidewire was inserted through the cordis delivery sheath to have a direct view and see the head of the sheath at the filter release position which is 3cm below the kidney vein and the guidewire was removed. The filter loader was inserted at the end of the delivery sheath and pushed into the delivery sheath with a solid push rod. There was no kinked noted on the sheath at any time during the procedure. There was no peri nor post procedural complications were noted. The event occurred during the procedure and there was no specific time provided after placement. Three available images were reviewed by the clinician. The first image provides a slightly blurred view of a brite tip catheter sheath introducer (csi) upon an active sterile back table. Of note are the presence of blood indicating the device has been used in the patient, a neat sever indicating the device has been separated by a sharp instrument, located slightly left of center, and an area showing the cannula has been pierced by a sharp object from within the lumen, located right of center. This may possibly be a barb of the ivc filter. The second image provides a slightly blurred view of an ivc filter in a cup with a clear fluid, likely saline. It is difficult to determine whether it is an optease or trapease filter as the quality of the photograph makes it difficult to discern the presence or absence of the hook of an optease filter. Nevertheless, it appears to be a cordis device. The filter is deployed. There is also the presence in the cup of a portion of plastic tube floating in the fluid. This appears to be a portion of the csi cannula that has been separated from the device. It is approximately the length of the ivc filter. The third image provides a view of the device within the patient from a monitor showing a radiographic image. The device is in the lower right corner of the screen, lying slightly above and to the left of the patient¿s pelvic girdle from a left femoral vein approach. The filter is sited within the delivery sheath cannula. There appears to be some distortion of the filter. The filter is sited within the delivery sheath cannula. There appears to be some distortion of the filter. There is a slight bend to the device and a possible compression at the distal tip. This may reflect the patient¿s anatomy but also possibly device handling. There is no obvious sign of a perforation of the cannula by the filter barb at this point in the procedure, however it may simply not be visible from this angle of view. The device will be returned for evaluation.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key9900877
MDR Text Key200383349
Report Number9616099-2020-03609
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Catalogue Number466F210A
Device LOT Number17891908
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial