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 Difficult or Delayed Positioning (1157)

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

Event Date 04/10/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: investigation is based on description of event and returned product.No imaging was provided.One complete set (except filter) was returned together with one extra femoral introducer system.Both femoral introducers were used; one of them with no damages and the other severely curved.The pistons could not be moved when pushing the release buttons, why introducers were cut and after placed in water the adherence was dissolved and the pistons moved freely.Investigation revealed no failure/damage to them.At distal tip of sheath ~11 cm were partly squeezed and the tip was flat/oval-shaped - the reason for these damages cannot be determined.The filter was not returned and no imaging was provided, why the exact reason for the un-expanded primary filter legs cannot be determined, but 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.The spring effect of all filters is verified by advancing the filter through a sheath before measuring the distances between the filter legs.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 filter was released during use.The 2 primary legs were open and very closely but not completely open during procedure.After one week, the doctor found the filter was offset /shift to the original position by contrast media.Then retrieved the filter.Patient outcome: 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: 6299214
• MDR Text Key: 66433261
• Report Number: 3002808486-2017-00192
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)140227(10)E2880996
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2013

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-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2012
• 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: 77
• Patient Weight: 78