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 Problems Difficult to Advance (2920); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-2-uni-celect.Similar to device under 510(k) k090140.Summary of investigational findings: investigation is based on event description and returned product.Investigation of the returned product found that, since the secondary legs were visible (sticking inside the hub) it is assumed that the filter was advanced through the hub without any difficulties.Secondary filter legs were found severely damaged when removed from hub, as if attempts had been made to withdraw the sticking filter through the hub after the reported resistance was noted.No resistance was noted when advancing the introducer through the sheath.Unable to determine reason for reported difficulties encountered when attempting to advance the introducer through the haemostatic valve.There is found 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 complainant: the doctor inserted the introducer into the patient using a femoral approach.He removed the wire & inner dilator as per ifu.The introducer would not go through the haemostatic valve.Doctor attempted it for a few minutes, but finally got stuck.The doctor cut the introducer below the valve to enable him to pass a wire & exchange it for a navalign filter set.

• 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: 5899266
• MDR Text Key: 52844463
• Report Number: 3002808486-2016-00961
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)140826(10)E2792627
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 02/09/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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