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 Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-jug-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter would not detach from the delivery set.The filter was removed from the patient and another device was used to complete the procedure.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.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on description of event and returned product.The jugular introducer with loaded celect-pt filter was returned inside original, but opened tray.The red safety lock was pressed, ie the system was unlocked.The introducer with the filter could easily be advanced through the protection sheath and when pressing the release mechanism the filter detached as intended.Based on these findings the exact reason for the difficulties encountered cannot be determined, but it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated".No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• 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: 7220954
• MDR Text Key: 98430122
• Report Number: 3002808486-2018-00187
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)201017(10)E3642462
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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 Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/19/2018
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR