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 Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "jugular access.While trying to resheath the filter, patient tortuosity caused the hook to elongate and render the blue button unusable.Tried using it for a second time and the hook wouldn't go in.Couldn't use that deployment device anymore.Customer used another filter of the same gpn to complete the procedure, but did it with femoral access." patient outcome: the complainant reported that the product did not cause or contribute to any adverse effects to the patient.

Manufacturer Narrative

Manufacturers ref#: (b)(4).Summary of investigational findings: it was reported that "jugular access.While trying to resheath the filter, patient tortuosity caused the hook to elongate and render the blue button unusable.Tried using it for a second time and the hook wouldn't go in.Couldn't use that deployment device anymore.Customer used another filter of the same gpn to complete the procedure, but did it with femoral access." no product was returned for investigation and based on the information provided only it would be inappropriate to speculate at what may or may not have caused the difficulties in repositioning the filter.Based on the information ¿patient tortuosity caused the hook to elongate and render the blue button unusable¿ it is assumed that the grasping hook somehow straightened, maybe during attempts to retract the filter back into the introducer and consequently, it slipped the filter and rendered the release button unusable.This assumption is supported by the information ¿tried using it for a second time and the hook wouldn't go in¿, as the straightened hook on the jugular introducer would cause difficulties in catching / releasing the filter in a second attempt.It is assumed that the filter eventually could be retrieved, since reported that the procedure was completed with another device from femoral approach.According to the instructions for use the pre-expanded filter can be repositioned if not in desired position by ¿carefully advance the introducer sheath over the filter.Reposition the system as desired, and again withdraw the introducer sheath and protection sheath until the protection sheath and jugular introducer handle are in contact with one another, completely exposing the filter.¿ there are adequate controls in place to ensure that this type of device is manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the device history record 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.

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: 10183137
• MDR Text Key: 199474462
• Report Number: 3002808486-2020-00637
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220905(10)E3894108
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3894108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1