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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: sales manager.Similar to device marketed under pma/510(k): k171712.Investigation is still in progress.

Event Description

According to initial reporter: difficulty is presented when entering the introducer of the system, deforming the main legs for optimal anchoring.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did require additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: since difficult to advance the filter through the introducer sheath the primary filter legs were deformed.The device was supposed to be returned for analysis, but despite several enquiries to date it has not been returned.However, photos provided showed a bloody celect-pt filter loaded to the femoral introducer with the primary filter legs still locked inside the femoral cup.The pre-expanded secondary legs were slightly deformed, as if the filter was twisted during advancement, but due to the quality of the photos the reported deformation of the primary filter legs cannot be confirmed.Based on these photos and the limited information provided the exact reason for the difficulties encountered when attempting to advance the filter through the introducer sheath cannot be determined, as the femoral introducer is advanced all the way though the sheath during manufacturing to ensure a proper advancement and in case of resistance the femoral introducer is destroyed.However, as to the slightly damaged filter reference is made to the instructions for use warning against rotating the preloaded filter inside the introducer system during advancement.And also, the ifu caution that attempts to retract the pre-expanded filter could damage the secondary filter legs or the caval wall.There are adequate controls in place to ensure that this device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final release, 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.

Manufacturer Narrative

Manufacturer ref# pr338422 summary of investigational findings: since difficult to advance the filter through the introducer sheath the primary filter legs were deformed.The complaint was reopened, since the complete uni device was returned.The introducer dilator was kinked close to the hub and the side-arm on the introducer sheath was squeezed.On the femoral introducer the shrink tubing was severely damaged and the red safety button was pressed down, ie the system was unlocked.The celect-pt filter was severely damaged with two secondary legs pushed upwards and nearly twisted around the filter.Consequently, these damages to the filter match the photos of the filter previously provided showing a bloody celect-pt filter loaded to the femoral introducer with the primary filter legs still locked inside the femoral cup, but with the pre-expanded secondary legs pushed upwards and twisted.Based on these findings the exact reason for the difficulties in advancing the femoral introducer with the filter through the sheath cannot be determined, but the damaged filter suggests it being rotated during the advancement or an attempt to retract the pre-expanded filter back into the sheath.Therefore, reference is made to the instructions for use warning against rotating the preloaded filter inside the introducer system during advancement and cautioning that attempts to retract the pre-expanded filter could damage the secondary filter legs or the caval wall.There are adequate controls in place to ensure that this device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final release, there is evidence that the dhr was fully executed.In addition, still 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® PLATINUM NAVALIGN UNISET 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: 12293175
• MDR Text Key: 265565068
• Report Number: 3002808486-2021-01687
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)240520(10)E4112607
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E4112607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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 Sex: Male
• Patient Weight: 95 KG