MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34502

Device Problems Malposition of Device (2616); Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Occupation: special procedures technologist.510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the physician attempted to put in a femoral celect filter.He deployed it and it landed crooked and one of the legs was sticking out at a weird angle.He then accessed the jugular vein, snared it, and attempted to deploy it again with the same result.At this point, he retrieved it and took it all the way out and placed a jugular celect filter with no issues." additional information received on 09aug2019: the physician said the significant tilt occurred when he pushed the blue deployment button.The physician did mention when he deployed the filter that the secondary struts looked like they were somewhat "off" (position wise) on the right side.Please see image provided by dm.The physician indicated this is the first time he has ever seen this.Patient outcome: the product did cause and contribute to the need for additional procedures: had to access the right jugular vein to go in and retrieve the tilted procedure.Then place another one.

Manufacturer Narrative

Manufacturers ref#: (b)(4).Summary of investigational findings: the user attempted to implant at celect filter by femoral approach.The user deployed the filter and it landed "crooked", suggesting that the filter tilted.Furthermore, one of the secondary filter legs was sticking out at a weird angle.The user accessed the jugular vein, snared the filter and attempted to re-deploy it, however same result occurred.The user retrieved the filter and took it out of the patient.The procedure was completed with a celect jugular filter set, and the filter was implanted successfully.No adverse effects on the patient was reported due to this occurrence.A single poor venogram image with an unknown imaging date was provided and reviewed in the complaint investigation.No image of the second attempt where the user re-deployed the filter was provided.The image demonstrates the celect-pt filter in what is presumed to be the infrarenal ivc, and an insignificant 10 degrees rightward tilt was present.The hook of the filter appeared to abut the right lateral wall of the ivc as a result of the slight tilt.Two of the secondary filter legs extended slightly more laterally than the primary filter legs, however, they did not clearly projects outside of the column of contrast and were considered normally oriented given the slight tilt.The image review concluded that the primary and secondary filter legs all appeared to be within the column of contrast and did not appear to be significantly disorganized or mal-oriented.There is a rightward tilt present, however, by definition, this is not a significant rightward tilt and would not affect the overall efficacy of the filter in this position.Furthermore, a celect-pt filter was returned and evaluated for the complaint investigation.One of the secondary filter legs was wrapped around a primary leg.The secondary leg was placed in the correct position during the evaluation, which resulted in an uneven distribution of the secondary legs.The diameter of the primary filter legs, the diameter of the secondary filter legs and the height between the primary filter legs and the secondary filter legs was all measured to be in accordance to specifications.It is not clear in the event description how the procedure went before deploying the filter.However, there are adequate controls in place to ensure the device was manufactured to specifications, including controls that assures no crossing and correct position of filter legs.Ifu warns about rotating the filter inside the introducer system or inside vena cava, which can compromise the performance of the filter.It is possible that the filter was rotated during the procedure / deployment which led to the reported event, and that the secondary filter leg crossed during retrieval of filter.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8943811
• MDR Text Key: 158617527
• Report Number: 3002808486-2019-01332
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)220625(10)E3868489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3868489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR