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

Model Number G48372

Device Problems Device Tipped Over (2589); Physical Resistance/Sticking (4012)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 05/04/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: unknown.Investigation is still in progress.

Event Description

Description of event according to initial reporter: placement of a cook celect filter on (b)(6) 2011 due to post deep vein thrombosis (dvt) and pulmonary embolism (pe) which subsequently clotted and was removed (b)(6) 2011 during a thrombolysis procedure.It was observed that the caudally oriented cook celect filter suffered some short leg displacement rendering it at risk for brakeage.At that point it was noted that the thrombus have significantly cleared about this filter including the thrombus soon at its cephalad aspect (b)(4).Additionally, a temporary celect filter was placed for use during the thrombolysis procedure on (b)(6) 2011 which was removed upon completion of the procedure and replaced with a third cook celect filter (b)(4).Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.The filter was successfully snared and removed with all legs intact.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: during thrombolysis 20 days after filter placement, it was observed that the ¿filter suffered some short leg displacement rendering it at risk for breakage¿.The filter was successfully removed with all legs intact.No product was returned for investigation and no images were provided.Therefore, based on the limited information provided the exact reason for the displaced secondary filter legs cannot be determined.However, it is noted that the filter was removed with all legs intact and that a temporary celect filter was placed for use during thrombolysis and removed after the completion.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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.

Event Description

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

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: 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 ; 56868686
• MDR Report Key: 12718188
• MDR Text Key: 278998141
• Report Number: 3002808486-2021-01935
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)120614(10)E2603641
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• Device Model Number: G48372
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2603641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female