MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: no product was returned and without the actual complaint device the exact reason for the grey button to stick cannot be determined.However, the red safety button may not have been pushed prior to pushing the release button when attempting to change from femoral to jugular introducer.Ifu: to release the filter from the femoral introducer, push the red safety button followed by the release button.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: grey button got stuck in handle when transferring from femoral to jugular approach prior to patient contact.Patient outcome: unknown as information was not provided.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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: 5895775
• MDR Text Key: 52726653
• Report Number: 3002808486-2016-00866
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)170401(10)E3200661
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2014
• Date Device Manufactured: 04/01/2014
• 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): Other