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

Model Number G48373

Device Problems Component Incompatible (1108); Difficult or Delayed Activation (2577)

Patient Problem Anxiety (2328)

Event Date 06/27/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# pr57607.During investigation of (b)(4) manufacturer ref: 3002808486-2022-00859.It was discovered that a complaint for this event was filed back in 28jun2012, the event is now considered reportable.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 Description

Description according to initial reporter: doctor was placed ivc filter when the filter did not release from the delivery system.When doctor went to retract the delivery system, the filter was still attached without the doctor knowing and the filter pulled into back to iliac vein.The doctor put the patient to sleep and when they pulled hard, the filter disengaged from delivery system.The filter was left in place and a new filter was placed successfully.It was explained to the rep.By the doctor that the filter left in place would pose no problems to the patient.The patient is in stable condition.Additional information from (b)(4) manufacturer ref.3002808486-2022-00859: 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 re-advanced 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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: as the filter would not release in the ivc, it was moved to iliac vein and released there.No evidence of injury after the repositioning and the filter was left in the iliac vein.Another celect filter was placed in correct position in the ivc.Only the femoral introducer was returned and the device failure analysis of 08aug2012 is still valid and remains unchanged; investigation found that the red safety cap was loosened and the release mechanism inside the introducer stuck because of coagulated blood.After separating the introducer and the release mechanism a mark was noted on the femoral cup, but the components were found working as intended.Based on these findings and the information provided the exact reason for the difficulties encountered, when attempting to release the filter cannot be determined.The instructions for use supplied with the device specified how to properly place the femoral introducer with the filter in correct position, to prepare for filter release, and following how to release the filter by pulling the red hub in one quick controlled motion until it contacts the pin vise.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.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 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.

• Brand Name: COOK CELECT FEMORAL 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
• MDR Report Key: 15417603
• MDR Text Key: 299852593
• Report Number: 3002808486-2022-00953
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483736
• UDI-Public: (01)00827002483736(17)140315(10)E2890276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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
• Device Operator: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2012
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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: 39 YR
• Patient Sex: Female