MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G34309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section e3: non-healthcare professional.Section g4: pma/510 (k) # - k211875.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.20 devices in lot.No other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.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
It is alleged that the patient received a celect platinum inferior vena cava (ivc) filter on (b)(6) 2019.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 20532483
• Report Number: 3002808486-2024-00231
• Device Sequence Number: 8324662
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220205(10)E3820452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3820452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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: Life Threatening
• Patient Sex: Male