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 Retraction Problem (1536)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k211875.(b)(4).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 of event according to initial reporter: igtcfs-65-2-uni-celect (b)(4) opened for an ivc filter placement.Patient had no special considerations and was considered a routine case.In preparation of the first filter for jugular placement, the physician noticed that the filter looked more curved than normal on opening and it didn¿t load into the sheath as expected.When he tried to lock in the white stop mechanism it felt stiff and wouldn¿t connect as expected.He examined the device and said the buttons also felt stiff and not as he is used to, so this device was put to the side and another one was opened.On the first one the hooks failed to retract.This happened outside the body, and we didn¿t use it.The second igtcfs-65-2-uni-celect (b)(4) filter was then opened for prep for a jugular placement of ivc filter.The sheath again looked a little curved as seen in the first one, he describes it having a more pronounced angle.However, it did connect to the white stop mechanism, and they proceeded with the case.The filter was then deployed safely and as expected, however on de-hooking of the filter the hook did not retract fully back into the sheath.This mechanism was stiff and no matter what they tried it wouldn¿t go back fully inside the sheath.The sheath and hook were then removed, but the hook caught on the soft tissues of the patient¿s neck and resulted in the need for some soft tissue dissection at the site to remove it.This was the only additional procedure that was required to remove the device.The second seemed okay, but the hooks failed to retract post filter deployment and was very difficult to recover.Both filters were re-mounted for jugular deployment, but in several hundred deployments i¿ve never had this problem before.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter looked more curved than normal on opening and didn¿t load into the sheath as expected.The white stop mechanism felt stiff and would not connect as expected.The buttons felt stiff and the device was not used (b)(6).A second device was opened and looked curved, too, with a more pronounced angle, but the filter was connected.Following successful filter release, the grasping hook would not retract fully into the sheath.The sheath and introducer were removed, but the hook caught the soft tissue and some dissection was needed for removal.The patient did not experience any other adverse effects.The coaxial introducer sheath system, the femoral introducer, and the jugular introducer were returned.The introducer sheath was slightly pressed 12mm from the most distal tip and an indentation was noted in the tip itself.The jugular introducer was returned with the grasping hook exiting from the distal tip, straightened and bent in a 90° angle, thus preventing it from sliding back into original position.Based on these findings the exact reason for the difficulties encountered during attempt to reload the filter from femoral to jugular introducer in the first place cannot be determined.However, the reported difficulty in fully retracting the grasping hook into the sheath after successful filter placement may be explained by the angled grasping hook, if somehow damaged during the filter placement/release.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 qc release, 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® 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
• MDR Report Key: 14546314
• MDR Text Key: 293358368
• Report Number: 3002808486-2022-00750
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)250328(10)E4241377
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E4241377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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): Life Threatening