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 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k (2021 reports) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the case was planned to place a ivc filter through jugular vein.They found some resistance during advancing the filter delivery system through the sheath.Then they saw the filter delivery system is out of the sheath and is parallel with the long sheath.Finally, they removed the filter delivery system carefully through the broken part of sheath and out of patient body.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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: following resistance during advancement of the filter through the sheath it was noted that the delivery wire had penetrated the sheath.The delivery system was removed and no harm to the patient was reported.The pre-dilator, the coaxial introducer sheath system, the jugular introducer, and the femoral introducer with the celect-pt filter loaded were all returned.On the femoral introducer the safety button was not pressed down, ie the system with the filter was still locked and both introducer and attached filter seemed unused.Two slightly crossed filter legs could easily be uncrossed, and the filter regained its original shape.On the bloody jugular introducer the tip of the protection sheath was damaged and the grasping hook stuck, even after soaked in water.However, after cutting open the handle, the grasping hook moved freely and the introducer worked as intended.The introducer sheath had kinked 453mm from the distal tip and scratches/marks were noted 438-453mm from same.A penetration was noted 397-420mm from the distal tip, too and was likely caused by a primary filter leg.Based on these findings with the returned filter loaded to the femoral introducer, the exact reason for the difficulties encountered, when advancing the jugular introducer with the filter through the introducer sheath cannot be determined.According to instructions for use excessive force should not be exerted to advance the filter and under normal conditions the sheath is strong enough to accomplish the procedure.However, the sheath may kink if advanced through tortuous anatomy and the filter may be prone to penetrate the sheath wall, if advanced through a kinked sheath.There are adequate controls in place to ensure the 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

Additional information received 26aug2021: they found the delivery system is outside of the sheath at very beginning, then they removed out the filter delivery system very carefully.

• 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: 12364131
• MDR Text Key: 268027560
• Report Number: 3002808486-2021-01755
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)240202(10)E4068635
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E4068635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1