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 Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-2-uni-celect-pt.(b)(4).Summary of investigational findings: unfortunately, no product was returned and without the actual complaint device, it would be inappropriate to speculate at what may or may not have occurred based on the limited information provided and it cannot be determined why the filter "would not advance fully through haemostatic valve" in the first place.However, since the filter was damaged during removal, it is suggested that the filter legs were damaged when attempts were made to withdraw the femoral loaded filter through the haemostatic valve.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: product would not advance fully through hemostatic valve so removed and filter became damaged right femoral access gianes, flushed filter introducer positioned and venocavagram taken.Filter on femoral set put into introducer but would not advance fully through heamostatic valve so removed and filter became damaged.New filter set opened and placed with no further issue.Patient outcome: the patient did not experience any adverse effects 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; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6313896
• MDR Text Key: 67249844
• Report Number: 3002808486-2017-00347
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)190519(10)E3451048
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 02/09/2017
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1