MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

Device Problems Material Puncture/Hole (1504); Material Twisted/Bent (2981)

Patient Problem Perforation of Vessels (2135)

Event Date 07/18/2019

Event Type  Injury  

Event Description

According to the initial reporter, "trying to place a filter and trying to deploy the filter thru the sheath.While navigating a tight corner around the iliac veins, the hook on the top of the filter punctured thru the sheath.Femoral approach.Had to convert to neck approach for filter retrieval and followed up by filter replacement." according to representative: right femoral vein approach.Tight right iliac vein stenosis made for difficult traverse to the ivc.As sheath made the turn it kinked and the filter hook punctured through the sheath into the lumen of the iliac vein.They used a gtrs loop snare from jugular approach to retrieve the filter parking the tip of the snare next to the hook still mostly inside the delivery sheath.Once they snared the hook, they pulled it through the hole in the delivery sheath into the vessel then passed the retrieval sheath over the filter and removed.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 8896254
• MDR Text Key: 154370246
• Report Number: 3005580113-2019-00225
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220502(10)E3848755
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3848755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2019
• Distributor Facility Aware Date: 08/12/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2019
• Date Device Manufactured: 05/02/2019
• 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): Life Threatening
• Patient Age: 88 YR