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 Bent (1059); Failure to Advance (2524)

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

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-jug-tulip.Similar to device under 510(k): k090140.(b)(4).Summary of investigational findings: the jugular introducer, sheath, stopcock, y- fitting and the long dilator is investigated.The filter was not returned.The investigation revealed that the introducer was bend in the handle end.However, no influence on the function.The radiopaque sheath has a minor bend in the handle end.The remaining of the returned parts of the device seems normal.There was no problem in advancing the dilator all the way through the sheath.Why "the anchors got caught in the sheath and eventually prevented the filter from exiting" is unknown.However, the introducer sheath shall not cover the anchors.The bends in the handle end on the introducer and the 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 and filter introducer through tortuous anatomy.The evaluation of the product did not indicate a device failure.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: the device was used for ivc filter placement.There was no problem in the patient anatomy according to the physician's information.During the procedure, the filter would not exit the sheath.Whole delivery system was removed from the patient.When the user inspected the failure outside the patient, it was found that anchor/anchors was/were caught on the sheath, which eventually prevented the filter from exiting.Then, the user moved the sheath applying some force to try to make the filter exit, then the filter exited the sheath and expanded.However, the user decided not to use the device anymore in consideration of risk.Since there was no other gunther jug available, gunter fem was used instead after puncturing the fa and the filter was placed successfully.Patient outcome: there have been 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: 6299606
• MDR Text Key: 66438247
• Report Number: 3002808486-2017-00270
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)161219(10)E3167462
• 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: 05/01/2014

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: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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
• Patient Age: 78 YR