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

Model Number DL900J

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and eight months later, filter retrieval was scheduled, attempted to snare the inferior vena cava filter percutaneously but after a prolonged attempt filter removal was unsuccessful, and the filter was remained in place.This was apparently because the hook of the filter was either embedded into the wall of the inferior vena cava or covered with fibrin sheath.After ten days, patient was reported abdominal and lower back pain one day after attempted filter removal and that has been persistent since that time.A computerized tomography scan of abdomen and pelvis showed phlebitis of inferior vena cava and bilateral iliac veins and reported thrombus in the inferior vena cava filter.Moderate nonspecific retroperitoneal fat at level of inferior vena cava filter and extended to origin of bilateral external iliac arteries, that was might be related to recent attempt made at inferior vena cava catheter removal and resultant infection was suggested.Therefore, the investigation is confirmed for alleged retrieval difficulties.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.(expiry date: 10/2018).

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 unable to be retrieved.The device has not been removed after unsuccessful percutaneous removal attempt.The patient reportedly experienced abdominal and back pain; however, 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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10300789
• MDR Text Key: 199640165
• Report Number: 2020394-2020-04710
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2020

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: 10/31/2018
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFZJ0094
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ALUM/MAGNESIUM/SIMETHICONE, MAGNESIUM HYDROXIDE; FAMOTIDINE, VANCOMYCIN; HEPARIN, ELIQUIS, AMLODIPINE, CARVEDILOL; LORAZEPAM, SODIUM CHLORIDE, DOCUSATE SODIUM; ONDANSETRON, ACETAMINOPHEN, BISACODYL; PIPERACILLIN/TAZOBACTAM, NICOTINE, OXYCODONE; WARFARIN, CLONIDINE, LABETALOL, HYDRALAZINE
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 69