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

Model Number	G48373
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Anxiety (2328)
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a cook celect filter was then placed for our sheath.The sheath was then backed up to uncover the filter, and the filter was deployed under direct flouroscopic visualization.However,it would not release.Ultimately the filter was moved from the ivc into the right iliac vein, and due to the mal-deployment of the filter and the inability for it to release from the push rod of the cook celect delivery system, the decision was made to leave it in the right iliac vein.It should be noted that prior to this the patient became increasingly anxious and uncomfortable, and due to the patient's morbid obesity and concern for adequate airway control with increasing doses of conscious sedation, we elected to convert the case to general endotracheal anesthesia, and as such the anesthesia service intubated the patient while we paused to get this completed.Once this was done, we re-engaged into the procedure.The sheath in the groin was used to help disassemble the push shaft assembly of the cook celect device from the actual ivc filter, which was ultimately deployed in the distal external iliac vein.Thereafter a wire was readvanced up into the inferior vena cava, and the inner dilator of the sheath was used to allow the sheath to re-access the ivc.Power injection venography was then performed of the vena cava and iliac system, with findings and interpretation noted above.Intravascular ultrasound was reintroduced to evaluate the iliac and ivc to make sure that there was no evidence of injury to those structures after repositioning of the previous filter.Thereafter, a new cook celect ivc filter was placed, and this was placed in the correct position just below the renal vein confluence.Patient outcome: patient was awoken and extubated in the operating room and sent to recovery in stable condition.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).During investigation of (b)(4) manufacturer ref: 3002808486-2022-00859 it was discovered that complaint (b)(4) manufacturer ref: 3002808486-2022-00953 was filed back in 28jun2012 for this event.Therefore this complaint will be closed-cancelled and all future information will be handle in (b)(4) manufacturer ref: 3002808486-2022-00953.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: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14828930
• Report Number: 3002808486-2022-00859
• Device Sequence Number: 17306467
• Product Code: DTK
• UDI-Device Identifier: 00827002483736
• UDI-Public: (01)00827002483736(17)140315(10)E2890276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2014
• Device Model Number: G48373
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2890276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female