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

Model Number G34309

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/19/2019

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: the physician experienced difficulty deploying the filter.He had to push the button approximately 3 times to get the filter to release ((b)(4)).The filter tilted as well ((b)(4)).This filter was ultimately used to complete the intended procedure.The approximate diameter of the vena cave (after measuring) was 28.3mm's.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Upon investigation it was discovered that two complaints were logged to cover for same procedure.One complaint related to difficult to release (b)(4) (fda ref# 3002808486-2019-01666) and one complaint related to tilt (b)(4) (fda ref# 3002808486-2019-01664).As tilt could be an effect of difficult to release the complaint will be handled under (b)(4) (fda ref# 3002808486-2019-01664).(b)(4) (fda ref# 3002808486-2019-01666) will therefore be closed/cancelled with reference to pr278590 (fda ref# 3002808486-2019-01664).This report is required by the fda under 21cfr 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.

• 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: 9165215
• MDR Text Key: 187998934
• Report Number: 3002808486-2019-01666
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220228(10)E3826886
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3826886
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1