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 Device Tipped Over (2589); Material Twisted/Bent (2981)

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

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: cat lab manager.Pma/510(k): k171712.Investigation is still in progress.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: (b)(6) 2020 - (b)(4) - when removed from the packaging, it was observed that the secondary leg was flipped up.The device did not make patient contact.The procedure was successfully completed with another device from the same lot (device from (b)(4)).On (b)(6) 2020 - (b)(4) - the rep was informed that the patent foramen ovale (pfo) closure procedure was performed through the celect platinum filter.Typically, the filter would be placed after the pfo procedure.Due to a miscommunication at the lab level, the filter placement was completed prior to pfo closure.During pfo closure, towards the end of the case, it was noticed that a secondary strut of the filter was bent and that the filter was tilted.A pig tail catheter was used to straighten out the secondary strut and the filter successfully.Patient outcome: no adverse effects was observed to the patient due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the rep was informed that the patent foramen ovale (pfo) closure procedure was performed through the celect platinum filter.Typically, the filter would be placed after the pfo procedure.Due to a miscommunication at the lab level, the filter placement was completed prior to pfo closure.During pfo closure, towards the end of the case, it was noticed that a secondary strut of the filter was bent and that the filter was tilted.A pig tail catheter was used to straighten out the secondary strut and the filter successfully.According to instruction for use filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/ perforation; and (or) result in loss of filter efficiency.Based on the provided information the likely cause of event is that the patent foramen ovale closure procedure caused the secondary strut to bend and the filter to tilt.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.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: 10023003
• MDR Text Key: 190431735
• Report Number: 3002808486-2020-00509
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230221(10)E3955407
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3955407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 79