MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Occupation: product coordinator.Pma/510(k): k172557.Investigation still in progress.

Event Description

Description of event according to initial reporter: "gunther, jugular device.Customer said it would not release from the hook, and when it did it was more cranial than intended at final placement." "dr.Said this is the second time he has experienced this issue, unsheathed, pushed red button, then black button and it wouldn't release the hook.This time he tried twisting to a 10-15 degree angle and it would still not release, then he ended up resheathing it and it unhooked inside the sheath, so it ended up higher than he intended.He said he did not retrieve it because it will still work it the current position, but did want to report it." patient outcome: the complainant reported that the product did not cause or contribute to any the adverse effects to the patient.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: physician reported he was unable to release filter from the hook.Then the physician tried twisting to a 10-15-degree angle, and it would still not release, then he ended up resheathing it and it unhooked inside the sheath, so it ended up higher than he intended.He said he did not retrieve it because it will still work it the current position.No adverse effects to the patient due to this event.It was assessed that because no non-conformances were detected, 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.According to instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Ifu warns do not rotate the expanded filter inside the vena cava.Doing so may compromise the performance of the filter.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information the exact cause could not be established, however a likely cause is that excessive tension prevented the filter from being released.No evidence to suggest that the device is not manufactured according to specification.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: GUNTHER TULIP 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: 10182999
• MDR Text Key: 196077474
• Report Number: 3002808486-2020-00634
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)230225(10)E3956377
• 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: 09/07/2020

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 Expiration Date: 02/25/2023
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3956377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1