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

Model Number G34505

Device Problems Material Puncture/Hole (1504); Material Twisted/Bent (2981)

Patient Problems Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4) blank fields on this form indicate the information is unknown or unavailable.Occupation: non-healthcare professional.Pma/510(k) #: k171712.Investigation is still in progress.

Event Description

Description according to initial reporter: "trying to place a filter and trying to deploy the filter thru the sheath.While navigating a tight corner around the iliac veins, the hook on the top of the filter punctured thru the sheath.Femoral approach.Had to convert to neck approach for filter retrieval and followed up by filter replacement." patient outcome: the patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Event Description

Additional information received (b)(6) 2019 from rep.: right femoral vein approach tight right iliac vein stenosis made for difficult traverse to the ivc.As sheath made the turn it kinked and the filter hook punctured through the sheath into the lumen of the iliac vein.They used a gtrs loop snare from jugular approach to retrieve the filter parking the tip of the snare next to the hook still mostly inside the delivery sheath.Once they snared the hook, they pulled it through the hole in the delivery sheath into the vessel then passed the retrieval sheath over the filter and removed.

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.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 previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: femoral approach was used for filter placement, but introducer sheath kinked when it made the turn in the right iliac vein.The filter was navigated through the tight corner, but the hook of the filter perforated the introducer sheath.The user changed to jugular approach where the filter was retrieved, followed by filter replacement.No adverse effects on the patient has been reported due to this occurrence.An introducer sheath was returned for evaluation.A perforation was found 222 mm from the distal end.Furthermore, several kinks were found 82mm, 102mm, 147mm, 163mm, 222mm and 517mm from the distal end.It is most likely that the introducer sheath kinked due to the patient anatomy.Ifu states that excessive force should not be used to advance the filter through the introducer sheath system.However, it is possible that the user felt difficulty in advancing the filter through the kinked introducer sheath, and therefore felt the need to exert excessive force, leading to the reported event where the filter perforated the introducer sheath.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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.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.

• Brand Name: COOK CELECT PLATINUM NAVALIGN UNISET 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: 8877439
• MDR Text Key: 158871249
• Report Number: 3002808486-2019-01159
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220502(10)E3848755
• 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,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3848755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 88 YR