MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-UNI-CELECT

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-uni-celect.(b)(4).Similar to device under 510(k) k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the physician met resistance and could not advance the filter through the blue sheath.When the physician inserted the filter into the blue sheath halfway, it could not be advanced and also could not withdraw.So the physician removed the filter together with the sheath.Then the physician changed to another new device to finish the procedure successfully.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: investigation is based on description of event stating "the physician met resistance and could not advance the filter through the blue sheath.When the physician inserted the filter into the blue sheath halfway, it could not be advanced and also could not withdraw.So the physician removed the filter together with the sheath.Then the physician changed to another new device to finish the procedure successfully." and returned device.The introducer, the filter and the sheath are returned.The filter is heavily deformed mainly one primary leg and 5-6 secondary legs.The sheath is cut over approx.Midway.The proximal part has an ~25 mm.Long tear, and the distal end has a penetration mark and marks from almost-penetrations.In addition, there are several minor kinks.The incident is undoubtedly the result of penetration, probably caused by a difficult approach.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.Cook medical will continue to monitor for similar events.

• Brand Name: COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET
• 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 DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6816049
• MDR Text Key: 83692321
• Report Number: 3002808486-2017-01656
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002456228
• UDI-Public: (01)00827002456228(17)180928(10)E3499880
• 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
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI-CELECT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/01/2017
• Device Age: 10 MO
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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: 27 YR
• Patient Weight: 67