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

Model Number G52916

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to the initial reporter: approach was gained from the right internal jugular vein.After placing terumo's radifucus 0.035" 150cm, the sheath introducer from the gunther set was advanced to the ivc over the wire guide.The wire guide and introducer were removed from the sheath, then the filter introducer from the set was advanced through the sheath.However, the physician felt resistance which seemed that the filter introducer was caught inside the sheath.Since the filter introducer could not be advanced though the physician tried to advance it several times, it was removed from the patient as a unit with the sheath.After removal, a kink in the sheath was confirmed.Another manufacturer's ivc filter (piolax, aln) was used instead to complete the procedure.There have been no adverse effects to the patient reported.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4) summary of investigational findings: resistance was felt when attempting to advance the jugular introducer through the sheath.After removal from the patient a kink was noted in the sheath.The procedure was completed with another device without any harm to the patient.No device was returned for analysis and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the difficulties encountered, when attempting to advance the jugular introducer with the filter through the sheath.However, it is noted that a kink was found in the sheath after removal, but to determine the reason for the kink, would be pure speculation based on the information provided.There are adequate controls in place to ensure that the device is manufactured to specifications.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 12915049
• MDR Text Key: 282720021
• Report Number: 3002808486-2021-01982
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)240311(10)E4084508
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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 Expiration Date: 03/11/2024
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4084508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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