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 Bent (1059); Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 06/17/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-2-uni-celect.Similar to device under 510(k) k121629.Summary of investigational findings: the inspection of the manufacturing records indicated no abnormalities for this unit and nothing from device record history indicates that this device was not manufactured according to specifications sheath including femoral filter introducer with filter still attached was returned for investigation.Femoral cup completely free of sheath, why it is possible to release filter if activating filter release mechanism.The red safety lock was pushed, however, filter was not released.The eight secondary filter legs are completely deformed.Kink on sheath approximately 26cm from distal end.Sheath tip had several marks because filter was retracted into sheath.No other indications on filter sheath.System filled with coagulated blood, however, it was possible to push the grey release mechanism to release the filter.The four primary legs are slightly deformed where legs are free of cup.Introducer was retracted through sheath without any difficulties.No kink on introducer or sheath which indicates that filter was out of sheath when primary legs where slightly deformed.Based on the physical investigation no evidence to suggest that device was not manufactured according to specifications.Since secondary filter legs are bending upwards, attempts may have been made to retrieve the pre-expanded filter after discovering "the filter was accidently partially deployed in the iliac vein" or "when some attempts were made to try and retrieve the filter but to no avail" at (b)(6) hospital.However, according to ifu attempted retraction of a pre-expanded filter may damage filter: "once the metal mount point is past the tip of the sheath the secondary legs of the filter are expanded.The filter may be repositioned only by advancing the filter; retracting the filter could damage the secondary legs or caval wall." cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: a 'celect' filter has been placed in a heavily pregnant lady.The indication was for dvt in the iliac vein.Problems arose while trying to place the filter & the filter was accidently partially deployed in the iliac vein."as per complaint form": the patient was being treated at another hospital, (b)(6) hospital was informed that the patient was being blue lighted from (b)(6), upon arrival ,the patient was observed to still have the celect navalign femoral delivery system still in situ at the groin.A single shot fluro image was taken of the groin where it could be seen that the filter had been partially deployed.Somehow the filter was wedged in the iliac vein with the primary centering legs bent at a 90 degree angle to the filter and all 8 legs were twisted and pointing towards the bifurcation of the iliac veins.Some attempts were made to try and retrieve the filter but to no avail.It was decided that because of the patient starting to have contractions it would be best to place a ivc filter from the jugular.Unfortunately, access was difficult on the right side so the decision to puncture the left was made and successful deployment of an infrarenal filter.After the filter was placed the patient was taken to surgery for a general anaesthetic, femoral cut down and caesarean section to deliver the baby.Patient outcome: a section of the device did not remain inside the patient's body.The patient did require additional procedures due to this occurrence.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.

• 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: 5887964
• MDR Text Key: 52490178
• Report Number: 3002808486-2016-00855
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)170228(10)E3188991
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 27 YR