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); Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-2-uni-celect, name and address for importer site: (b)(4).Similar to device under k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: this patient, a (b)(6) pregnant woman, is severely obese.The point of the internal jugular vein puncture was elevated about 1cm because of the confined space.The vessel was smoothly dilated with an expansion tube and the deep vein thrombosis involving the opening of inferior vena cava looked normal under angiography.The filter was introduced then but trapped when passing through the jugular vein.After analysis, the reason was that the jugular vein was too short and steeply angled.Then the filter and sheath were moved back and forth together, trying to make the sheath get through the bending position of the vein, but failed.After several attempts, the sheath was ruptured and then withdrawn together with the filter.The filter was in good shape.After that, a new 8f sheath was used to strengthen the supporting force of the vessel but still couldn¿t pass through the bending position.Then the sheath and the filter were withdrawn together.The filter was bended then and could no longer be used.After talking to the patient, she agreed to implant a new filter through the right femoral vein, which succeeded eventually.The thrombosis was aspirated by long sheath.The patient showed no adverse reaction.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: the celect filter, the blue sheath, and the jugular introducer were returned.The filter was correctly shaped and without damages.On the sheath a penetration was noted approx.33cm from the fitting, an incipient penetration approx.35.5cm from the fitting, and a severe penetration from 41.5 to 42.5cm from the fitting.The exact reason for these penetrations cannot be determined, but since reported that "the filter was introduced then but trapped when passing through the jugular vein" and "then the filter and sheath were moved back and forth together, trying to make the sheath get through the bending position of the vein", it is suggested that the sheath was not in correct position prior to advancing the jugular introducer and the filter.According to ifu the sheath position must be verified by diagnostic imaging and when correct position is established, the dilator must be removed and the introducer can be advanced.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov 4632 DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6816257
• MDR Text Key: 83505796
• Report Number: 3002808486-2017-01663
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)191208(10)E3529630
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/01/2017
• Device Age: 7 MO
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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 Age: 22 YR