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

Model Number G34502

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Reporter occupation: non-healthcare professional.510(k)/pma: k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter began to deploy prematurely.The device was removed and everything was put on hold.Nothing was left in the patient.Patient outcome: the patient will require another of the same procedure to attempt a successful icv filter placement.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter began to deploy prematurely.The device was removed.The patient needed an additional procedure due to this event.Celect-pt filter was returned for product evaluation.Per product evaluation: there was four secondary legs damage.There is some textile at the filter this must have been added under the cleaning procedure before returning the product.No nonconformance at the hook.The cause for the prematurely deploy cannot be determined, based on the product evaluation.This kind of damage to the secondary legs is most likely seen if the filter is pulled back in the introducer sheath.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.According to the instruction for use do not exert excessive force to advance the filter through the introducer system.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information an exact cause for this event cannot be established.However, a possible cause is that excessive force during advancing the filter through the introducer system could contribute to the reported event.Cook medical will continue to monitor for similar events.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.

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: 10688564
• MDR Text Key: 212061806
• Report Number: 3002808486-2020-00951
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230826(10)E4011506
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4011506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention