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

Catalog Number IGTCFS-65-2-UNI-TULIP

Device Problem Positioning Failure (1158)

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

Event Date 08/30/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog number: igtcfs-65-2-uni-tulip.Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: both the jugular and the femoral introducer are returned.The filter sticks approximately 15 mm out of the tip of the sheath.Obvious marks from the primary filter legs are found on the tip of the sheath.The grasping hook is out of shape, consequently the filter got detached.The damages to the grasping hook are due to excessive force applied to the device.Based on the findings on the returned device it is most likely that the returned device is related to the initial event.The marks on the sheath indicate an attempt to cover the filter legs completely with the sheath and the damages on the grasping hook indicate that excessive force has been used to retract the filter into the sheath.According to the ifu the feet of the tulip filter must not be covered completely by the introducer sheath.Attempt of covering the feet on the tulip filter may cause damages to the sheath as seen on the returned device.Device is manufactured according to specification.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: standard jug approach used.The vessel was puncture as directed and the dilator and introducer placed into ivc.When ivc was introduced to the sheath placement was attempted.Initial placement was incorrect and tulip filter was re-sheathed.When retrieved it was noted that the feet of the tulip filter were caught on the radiopaque band of the sheath.The whole introducer and delivery system were removed another jug puncture was attempted but became detached remaining inside patient removed and 3rd jug used and successful.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 NAVALIGN 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: 6299349
• MDR Text Key: 66565263
• Report Number: 3002808486-2017-00215
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529264
• UDI-Public: (01)10827002529264(17)160612(10)E3099157
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• 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-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• 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 Outcome(s): Required Intervention