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

Model Number G34309

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a celect pt was prepped and followed per protocol.When it was time to deploy, the physician pressed the red button then the blue button, but the filter would not detach.Eventually it did, but the physician was not happy with the placement, so they used a retrieval set to reposition the filter.Patient outcome: no patient harm.No further action needed.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter would not detach after pressing the blue button to release.When it did detach, the placement was not acceptable, so the physician used a retrieval set to reposition.No patient harm and no further action needed.Three images from the time of ivc placement were provided for clinical assessment.Per clinical assessment, first image demonstrates an inferior venacavogram performed via a jugular approach with a flush catheter positioned at the confluence of the iliac veins.There is no scale to determine the exact diameter of the ivc but using the spine hardware as a frame of reference, the infra-renal ivc measures ~13mm.The infrarenal ivc does appear small in caliber supporting this calculation.Per clinical impression, the 2 fluoroscopic images demonstrate a celect platinum ivc filter in the infrarenal ivc without evidence of significant tilt or any other issue.It is presumed this is the final position of the ivc filter after repositioning the filter.A curved jugular introducer with protection sheath was provided for product evaluation.Blood/biological matter was present.Because of the blood/biological matter it has no release function.Therefore, it has to be soaked and then after it was possible to attach and release a filter.Per the product evaluation, the likely cause is that excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Review of device history record showed no evidence to suggest that the device was not manufactured according to specification.According to instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information, clinical assessment and product evaluation a likely cause is that tension during deployment prevented the filter from being released.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 JUGULAR 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: 9390134
• MDR Text Key: 184059954
• Report Number: 3002808486-2019-01869
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220926(10)E3902567
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3902567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1