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

Model Number G52918

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 06/27/2022

Event Type  Injury  

Event Description

Description of event according to initial reporter: the physician placed filter, no deviation from how he always places them, from the right femoral vein approach.Message was that the red ¿lock¿ on the ivc filter wasn¿t working properly.The filter would not deploy and then it ended up deploying in the sheath.They tried to resheath it since it was only partially out of the sheath, however that just messed the secondary struts up.Ultimately, the physician got internal jugular access and had to snare the sheath to hold it in place while the tech slowly retracted the deployment sheath.

• 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
• MDR Report Key: 15159101
• MDR Text Key: 297211002
• Report Number: 3005580113-2022-00087
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)250218(10)E4225464
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E4225464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2022
• Distributor Facility Aware Date: 07/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2022
• Date Device Manufactured: 02/18/2022
• 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