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

Catalog Number IGTCFS-65-UNI

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the jugular introducer, the femoral introducer and two dilators are returned.Filter is not returned.The femoral filter introducer is placed in the introducer sheath.A minor penetration of the introducer sheath appears approx.33 cm from the distal end.From the penetration to the tip of the introducer sheath incipient kinks appear.The jugular filter introducer is kinked approx.3 cm from the handle end.The root cause for this event can not be explained.However, it is most likely difficult access.Unsure why femoral introducer was inside sheath upon return, as jugular approach was attempted afterwards.The root cause of the difficult advancement via femoral approach is most likely due to the reported tortuous anatomy.The root cause for unable to release the filter via jugular approach is most likely due to the kink in the handle end.The kink in the handle end is most likely also due to the reported tortuous anatomy as for the femoral approach.Under normal conditions the sheath is strong enough to accomplish the procedure, but it has been seen before that the sheath may kink if somehow exposed to excessive force e.G.Due to tortuous anatomy.If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall.No evidence to suggest that device was not manufactured according to specifications.Cook medical will continue to monitor for similar event.

Event Description

Description of event according to initial reporter: patient with deep vein thrombosis.Conducted the procedure on (b)(6) 2014.The physician had to retrieve the filter from the patient due to the blood vessel was too tortuous while inducted half way through arteria femoralis.Purple sheath was found broken while withdrew from the patient.Then the physician tried to puncture jugular vein, and inducted the device through jugular vein.The yellow sheath cannot move and the filter cannot be released while the filter delivery system was delivered to the target site.The physician had to withdrew the filter set from the patient.Procedure was finished by change another filter set according to the initial report.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.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• 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: 6275492
• MDR Text Key: 65666210
• Report Number: 3002808486-2017-00093
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 09/04/2014

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-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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