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

Model Number G52918

Device Problems Bent (1059); Device Handling Problem (3265)

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

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-1-uni-tulip.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: gaining access for this case was difficult.When inserting the filter delivery system into sheath, the doctor noticed that the hook of the filter was bent.The staff observed that the doctor tried to insert the delivery system incorrectly into the sheath and suspect that he bent the hook.They successfully completed the procedure with another filter.Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on even description and returned product.The femoral introducer with loaded tulip filter was returned.Investigation found the filter shape according to specifications, but the filter hook was severely bent with no damage to the hook material.Based on these findings the exact reason for the bent filter hook cannot be determined, but since reported that the filter was advanced "incorrectly into the sheath", this is supposed to have caused the damage.It is noted that the procedure was completed with another filter.Ifu: excessive force should not be used to place the filter.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6607123
• MDR Text Key: 76526741
• Report Number: 3002808486-2017-01149
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)200419(10)E3575220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/10/2017
• Device Age: 1 MO
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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 Age: 26 YR