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

Model Number G34505

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "the hook on the top of the filter punctured thru the sheath." 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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the hook of the filter perforated the introducer sheath.No additional details could be provided for the investigation, however, no adverse effects on the patient has been reported due to this occurrence.No product was returned for evaluation and no photos are available.Ifu states that excessive force should not be exerted.However, it is not clear in the event description whether the patient had a tortuous anatomy, if the introducer sheath kinked or if the user felt difficulty in advancing the introducer with the filter through the sheath.Due the insufficient information in the event description, the likely cause for the reported event cannot be established.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 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: 8877523
• MDR Text Key: 158695144
• Report Number: 3002808486-2019-01160
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)210912(10)E3772649
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3772649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1