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 Positioning Failure (1158); Appropriate Term/Code Not Available (3191)

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

Event Date 02/27/2014

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: sheath and long dilator returned.Three marks at sheath tip - two of them are distinct as if caused by a sharp object, probably the wire during the reported unsuccessful attempt(s) to insert the sheath.Exact reason cannot be determined, but based on information provided tortuous anatomy may be a contributing fact.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Ivc filter placement against dvt by right jugular approach was performed.After the dilation of the puncture site with a 7fr.Sheath (manufactured by terumo), the physician attempted to insert the sheath of the complaint device into the patient's body, but it could not.Therefore, he performed re dilation with a 9fr.Sheath (manufactured by terumo) and then, tried to advance the complaint sheath into the body again, but the result was the same.Thus, he changed the wire guide to a stiff one and retried the insertion, which was unsuccessful and the tip of the sheath got burred.Another igtcfs-65-jp-jug-tulip in another lot# was used alternatively, which could be advanced into the patient's body without problems.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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: 6299199
• MDR Text Key: 66462027
• Report Number: 3002808486-2017-00217
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)161128(10)E3160269
• 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: 02/28/2014

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-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2013
• 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