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 Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter tore through the sheath.The procedure was able to be finished with another filter."the filter perforated through the side wall of the delivery sheath." the patient's left jugular was prepped using ultrasound the internal jugular was punctured using a 5f micropuncture.A 5fr sheath was inserted over a.035 x 150cm bentson wire.A 5f x 65cm kmp cath was used to navigate down into the ivc.Bentson wire was removed and exchanged for a.035 x 145cm amplatz wire.Over the new wire the jug celect sheath was inserted to the level of l-3.An ivc cavogram was performed.The filter was then loaded into the sheath and met with much resistance with only one third of the filter shaft loaded in.We then moved the fluoro unit to the level of the chest and noted that the filter density was no longer following the sheath "line of travel" but was in fact poking through the side wall of the sheath.The filter was backed out of the sheath and exchange wire,.035 x 260cm,from another manufacturer was then inserted and the sheath removed and replaced by a filter from another manufacturer different company sheath.We deployed the new filter and preformed a post deployment cavogram.Additional information received 13sep2019: "filter still in sheath, never deployed".Patient outcome: no harm came to the patient.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the investigation is based on the event description and the returned device.It was reported that the filter penetrated through the side wall of the sheath during advancement.The procedure was completed with another device with no harm to the patient.The jugular introducer with protection sheath, the introducer sheath, the introducer dilator, the stopcock, and the celect-pt filter were returned.The introducer sheath was penetrated 276.5-285mm from the distal tip and kinks were noted 247 and 199.5mm from distal tip, respectively.On the protection sheath a dent was noted in the most distal tip and a kink was noted 52mm from distal tip, matching the filter hook inside, too.No damages were noted on the filter.The exact reason for the sheath penetration cannot be determined, but it is noted that the jugular introducer met with "much resistance" during advancement.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but like in this case the sheath may kink, if excessive force is used to advance it through tortuous anatomy and following the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.According to the instructions for use excessive force should not be used to place the filter.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 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: 9144049
• MDR Text Key: 187997036
• Report Number: 3002808486-2019-01561
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220621(10)E3867136
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3867136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 54