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 Difficult to Flush (1251)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2013

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, photos or imaging received to support the investigation.Based on the very limited information it is not possible to conclude an exact root cause for the event cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: could not flush the side port.Proceeded with case and no further problems.Patient outcome: prior to patient contact.

• 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: 5895770
• MDR Text Key: 52725567
• Report Number: 3002808486-2016-00926
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)160318(10)E3061503
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/25/2013

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2013
• Date Device Manufactured: 03/01/2013
• 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