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 Activation Problem (4042)

Patient Problem No Information (3190)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device under pma/510(k): k171712.Summary of investigational findings: the investigation is based on the event description and the returned device.Only the femoral introducer was returned for investigation.Approx.13.4cm of the distal end was found slightly curved and the red safety button was pressed, ie the system was unlocked.The femoral cup stuck inside the introducer with hardened contrast/blood, but after dissolving it in water, the cup moved freely and the release mechanism worked as intended and was found according to specifications.During manufacturing processes there are adequate controls in place to ensure correct placement of the spring as well as correct position of the safety button and the release button in the handle.Therefore, the exact reason for the difficulties encountered cannot be determined, but since the release button was pressed and since reported that "the filter might be pre-released, so it was hard to move back the sheath when he wanted to release it", it is assumed that the filter unintendedly released from the unlocked introducer inside the sheath and that the hooks of the released primary filter legs caused the difficulties encountered when attempting to pull back the sheath.However, based on the information provided and since only the femoral introducer was returned, it is assumed that the filter was placed in the correct position without any adverse effects to the patient.The device history record was reviewed with no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the red security button has been pressed before the filter is released.Additional information received 11jan2020: "the device was used on the patient, but i have confirmed with the doctor when the event happened.The doctor confirmed he didn¿t depress the red safety button before he wanted to release the filter.He thought it¿s hard to move back the sheath, checked the device then he saw the red safety button was depressed".Patient outcome: the patient did not require any additional procedures due to this occurrence.The complainant did not report any adverse effects on the patient due to this occurrence.

• 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; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 9641258
• MDR Text Key: 184057834
• Report Number: 3002808486-2020-00123
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)211218(10)E3808863
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3808863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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