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

Model Number G52918

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-1-uni-tulip.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the user was inserting the ivc filter into the introducer, as the filter was passing the common iliac, the gunther tulip punctured through the introducer.The user attempted to pull back, but the device became stuck and the user removed the introducer and filter together.In this process the vessel was damage; no repair needed.A new device was opened and the procedure was able to be completed 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: no product was returned and no imaging was provided to assist the investigation.Therefore, it would be inappropriate to speculate at what may or may not have occurred and why the tulip filter passed through the introducer, when passing the common iliac.However, it is reported that the vessel was damaged, when attempts were made to remove the introducer and the filter together and therefore it is suggested, that the filter hook and some secondary filter legs penetrated the sheath during advancement and stuck in the penetration during retrieval attempt.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.It is noted, that no vessel repair was needed and that the procedure was successfully completed with a new device.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended during the procedure.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL 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 4632 DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6823340
• MDR Text Key: 83804070
• Report Number: 3002808486-2017-01665
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)200518(10)E3586421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2017
• Device Age: 2 MO
• Date Manufacturer Received: 08/04/2017
• Date Device Manufactured: 05/18/2017
• 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: 91 YR