MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the four malfunctions were provided and a lot history review was performed.The devices for six malfunctions has not been returned for evaluation, however, for two malfunctions images were provided.Medical records were provided for six malfunctions.For one malfunction investigation is confirmed for perforation of the inferior vena cava (ivc); however, the investigation is inconclusive for the filter tilt.Investigation confirmed for perforation of the inferior vena cava (ivc) and filter tilt for 3 malfunctions.For one malfunction investigation is inconclusive for perforation of the inferior vena cava (ivc) and filter tilt.For one malfunction based on medical record review investigation identified perforation and tilt.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(lot number: unknown).

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model rf320j vena cava filter allegedly experienced tilt and perforation.These reports were received from various sources.All six malfunctions involved a patient with no reported patient consequences.Of the six reported patient, four patients ranged from 45 ¿ 65 years of age, three were female and three were male; however, patients weight was not provided.

Manufacturer Narrative

H10: the lot number for the three malfunctions were provided and a lot history review was performed.The devices for six malfunctions has not been returned for evaluation; however, medical records were provided and reviewed for six malfunctions.Medical images were provided and reviewed for three malfunctions.For one malfunction, the investigation is confirmed for perforation of the inferior vena cava; however, the investigation is inconclusive for the filter tilt.For four malfunctions, the investigation confirmed for perforation of the inferior vena cava and filter tilt.For one malfunction, migration (a0104) code was additionally added and the investigation is confirmed for perforation of the inferior vena cava, filter tilt and migration.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: d4 (lot number: unknown), g3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes six malfunctions.A review of the reported information indicated that model rf320j vena cava filter allegedly experienced tilt and perforation.These reports were received from various sources.All six malfunctions involved a patient with no reported patient consequences.Of the six reported patient, five patients ranged from 45 ¿ 69 years of age, three were female and three were male.One patient weight was 242 lbs.All other details of the patients were not provided.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10306474
• MDR Text Key: 199845350
• Report Number: 2020394-2020-04826
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF320J
• Device Lot Number: GFSF2672, GFQG3633, GFQF0399
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/28/2021
• Patient Sequence Number: 1