MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

Catalog Number IGTCFS-65-2-UNI-TULIP

Device Problem Positioning Failure (1158)

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

Event Date 01/09/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: only the filter was returned.Two primary legs were out of shape.All four secondary legs/blades were severely deformed, two of which were elongated/stretched parallel to their primary legs.Hardened blood was noted close to the clip bushing.Unable to determine exact reason for difficulties encountered, but due to the damages to the filter legs, it is suggested that after placement and withdrawal of sheath attempts were made to withdraw the expanded filter into the sheath.According to ifu "the pre-exposed filter can be advanced, but never pulled back into the sheath.Doing so will damage the shape of the filter." cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: filter was not properly loaded in the femoral system, one of the filter legs was outside the capture tip.Reloading into the femoral system was not possible jugular procedure was not indicated due to the patient was in aic.Patient outcome: patient outcome is unknown as not provided by the reporter.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6272082
• MDR Text Key: 65912249
• Report Number: 3002808486-2017-00067
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529264
• UDI-Public: (01)10827002529264(17)150823(10)E2966516
• Combination Product (y/n): N
• Reporter Country Code: CY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2012
• 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