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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt.Summary of investigational findings: investigation is solely based on description of event since no product was returned and no imaging provided.Given the limited information provided, it would be inappropriate to speculate on what may have led to the difficulties encountered when attempting to release the filter.It is noted, that the device was removed from the patient and a new device was used to complete the procedure.It is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated." no evidence to suggest that this 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 filter would not release from hook.The device was removed from the patient and a new device was used to complete the procedure.Patient outcome: the patient didn't have any adverse effects due to this occurence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6217043
• MDR Text Key: 63692218
• Report Number: 3002808486-2016-01614
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)180604(10)E3335975
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Date Device Manufactured: 06/04/2015
• 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