MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM; VENA CAVA FILTER

Model Number DL900J

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Blood Loss (2597); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.Four days followed by, patient had an ivc laceration (2.5l blood loss) possibly due to the ivc filter.Filter was retrieved from ivc and repair of lacerated ivc from the ivc filter.Therefore, the investigation is confirmed for filter limb perforation, as the filter limb perforated the ivc wall and caused the blood loss.Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into organs.The device was removed via abdomen and neck by broken out several arteries and kidney.The current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Four days followed by, patient had an ivc laceration (2.5l blood loss) possibly due to the ivc filter.Filter was retrieved from ivc and repair of lacerated ivc from the ivc filter.Therefore, the investigation is confirmed for filter limb perforation, as the filter limb perforated the ivc wall and caused the blood loss.Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into organs.The device was removed via abdomen and neck by breaking out several arteries and kidney.The current status of the patient is unknown.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9201840
• MDR Text Key: 162677921
• Report Number: 2020394-2019-04057
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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 Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFBQ3064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN, SIMETHICONE, ENOXAPARIN; ACETAMINOPHEN, SIMETHICONE, ENOXAPARIN; DOCUSATE SODIUM, FUROSEMIDE, DILTIAZEM CD; DOCUSATE SODIUM, FUROSEMIDE, DILTIAZEM CD; HYDROCODONE-ACETAMINOPHEN, IBUPROFEN; HYDROCODONE-ACETAMINOPHEN, IBUPROFEN; PANTOPRAZOLE, ASPIRIN; PANTOPRAZOLE, ASPIRIN; ACETAMINOPHEN, SIMETHICONE, ENOXAPARIN; DOCUSATE SODIUM, FUROSEMIDE, DILTIAZEM CD; HYDROCODONE-ACETAMINOPHEN, IBUPROFEN; PANTOPRAZOLE, ASPIRIN
• Patient Outcome(s): Required Intervention