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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problem Premature Separation (4045)

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

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: clinical lead.Pma/510(k) k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: on (b)(6) 2020 - physician used an ivc filter on saturday, the first one ((b)(4)) deployed while physician was inserting it, the button was not deployed.The second one ((b)(4)) deployed in the catheter in the body, which had to be retrieved with an ensnare and then redeployed.2 different lot numbers.On (b)(6) 2020 - we were placing a tulip filter ((b)(4)) from the internal jugular.I inserted the sheath and pulled the introducer and wire out.I was getting ready to load the filter in the sheath and when physician handed me the catheter with the filter loaded in it the filter popped out onto the table.The physician said he did not deploy the filter and did not press the safety button.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: two filter were used during the procedure, the first one (b)(4), deployed while the physician was inserting it, the safety button was not pressed.The second one (this complaint) deployed in the introducer sheath inside the body.This was retrieved with an ensnare and then redeployed.No harms to the patient was reported.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.According to instruction for use excessive force should not be exerted in placement of the filter.The instruction for use warns never attempt to re-deploy a retrieved filter.Based on the provided information the exact cause is unknown, however a likely cause is that excessive force contributed to the reported event.No evidence to suggest that device was 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.

• 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: 9784815
• MDR Text Key: 182972187
• Report Number: 3002808486-2020-00268
• Device Sequence Number: 1
• Product Code: DTK
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR