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

Catalog Number IGTCFS-65-UNI

Device Problem Positioning Failure (1158)

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

Event Date 01/07/2013

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.Summary of investigational findings: only the jugular introducer, introducer dilator with sheath, dilator and peel away sheath are returned for investigation.No filter is returned, nor the femoral introducer system.Unknown if the filter is advanced by jugular or femoral approach.The returned parts appear to be unused since no contamination and no deviation to the appearance of a new/unused product.The description "the filter was lean after deployed.The two main leg were not complete deploy" is taken in as filter not expanding.Based on the limited information we are unable to determine exact reason for filter expanding difficulties.However, the filter may have been somehow obstructed from fully expanding, either due to a clot turning into fibrin formation or due to other biochemical mechanism during the procedure.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the filter was lean after deployed.The two main legs were not complete deployed.Retrieved the filter and changed to new one.Patient outcome: the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP 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: 6295392
• MDR Text Key: 66316334
• Report Number: 3002808486-2017-00190
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)130714(10)E2774153
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2011
• 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: 80
• Patient Weight: 80