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

Model Number	G48372
Medical Device Problem Code	Inadequate Filtration Process (2308)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person) not provided, information provided by onderlaw, llc.Occupation: non-healthcare professional.Investigation: new pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.This report includes information known at this time.A follow up report will be submitted should additional information become 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 "patient received a cook celect filter.Patient is alleging pe.Hospital and medical records have not been provided.".

• Brand Name: COOK CELECT 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: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14444966
• Report Number: 3002808486-2022-00729
• Device Sequence Number: 4518906
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)121122(10)E2673194
• Combination Product (Y/N): N
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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 Model Number: G48372
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2673194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2010
• 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