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

Catalog Number RF310F

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)

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

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation and medical records were not provided.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(device: 2907, 4001).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an unknown g2 vena cava filter allegedly experienced migration, malposition of device, obstruction within device, patient device interaction problem and detachment of device or device component.This information was received from one source.The event involved a patient with no known impact to the patient.The age and weight of the male patient were not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, medical records were provided and reviewed.The investigation is confirmed for filter tilt and perforation of inferior vena cava; however, the investigation is inconclusive for alleged filter migration, filter limb detachment and occlusion of the inferior vena cava filter.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g3, h6 (method).H11: b5, d1, d5 (product catalog no), h6 (result).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 one malfunction.A review of the reported information indicated that an rf310f vena cava filter allegedly experienced migration, malposition of device, obstruction within device, patient device interaction problem and detachment of device or device component.This information was received from one source.The event involved a patient with no known impact to the patient.The 80 years old male patient was 193 lbs.

• Brand Name: G2 FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10305714
• MDR Text Key: 199841161
• Report Number: 2020394-2020-04791
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1