MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problems Difficult to Insert (1316); Kinked (1339)

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

Event Date 06/30/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: a mark which is almost a penetration is located approx.26 cm from the fitting, a penetration is located approx.27.5 cm from the fitting, a minor kink is located approx.33 cm from the fitting and furthermore, another mark which is almost a penetration is located approx.33 cm from the fitting.It is presumed that difficult access is the root cause for this event.The kink and perforation marks on the introducer sheath indicate that excessive force has been applied when the introducer was advanced.Under normal conditions the sheath is strong enough to accomplish the procedure, but the introducer sheath may bend if excessive force is used to advance the introducer sheath and filter introducer through tortuous anatomy.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: a male patient underwent ivc filter placement by right jugular approach.The anatomy of the patient was suitable for the procedure.When the physician was advancing the filter into the lesion through the sheath, resistance was felt.Therefore, the situation of the device was checked under fluoroscopic control, which confirmed that the leg of the filter was penetrating the sheath.As the filter could be retracted back into the sheath by withdrawing the introducer a little, the whole system was retrieved out of the body carefully.The retrieved sheath was checked outside the body, confirming the mark of the penetration on it.However, as there were no alternative filters at the stock of the hospital, after checking that filter advancement through this damaged sheath was possible outside the body, the sheath was flushed and reinserted into the body to continue the procedure.When advancing the filter into the lesion through the damaged sheath, resistance was felt at the same place where resistance was encountered last time.However, after confirming that no legs were penetrating the sheath under the fluoroscopic control, the whole system was advanced through the point where resistance was felt and the procedure was continued.The filter could be placed in the body finally.Patient outcome: no adverse effects to the patient.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• 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: 6275496
• MDR Text Key: 65666381
• Report Number: 3002808486-2017-00090
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)170220(10)E3186016
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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