MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Device Tipped Over (2589)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Investigation is still in progress.

Event Description

(b)(6) 2012, implant and retrieval report: "an inferior venacavogram was performed.The filter was delivered through the sheath and deployed.It is noted that there is some tilting of the ivc filter with respect to the ivc.An attempt to place the filter without as much tilt, the placed filter was retrieved after a 035 guidewire was advanced to the delivery sheath and delivery sheath was removed." "a new ivc filter was then deployed through the sheath.".

Event Description

Additional information received on 18feb2021: the right internal jugular vein was punctured under ultrasound guidance with a 21-gauge micropuncture needle and wire guide was inserted.The sheath was advanced over the guidewire into the inferior vena cava.An inferior venacavogram was performed.The filter was delivered through the sheath and deployed.It is noted that there is some tilting of the ivc filter.An attempt to place the filter without as much tilt a retrieval sheath was advanced and the filter was snared and retrieved without difficulty.A new ivc filter was deployed and a follow up inferior venacavogram was performed.The patient tolerated the procedure well without immediate complications.

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the filter tilted after deployment.After a failed retrieval attempt the filter was snared and retrieved without any complications and another filter was placed.No imaging was provided and the information in the report is very sparse and not very detailed.Thus, no information regarding the patient¿s anatomy, medication, performance status etc.Is available.Also, only very little information about the procedures is available and consequently the exact reason for the tilted filter cannot be determined.The patient did not suffer any harm and the result of the retrieval and replacement of the tilting ivc filter had only nuisance and slightly prolonged procedural time as consequence.There are adequate controls in place to ensure the device was manufactured 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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11342064
• MDR Text Key: 243994670
• Report Number: 3002808486-2021-00130
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 06/22/2021
• Supplement Dates FDA Received: 02/24/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 87