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

Catalog Number UNKNOWN G2

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Patient-Device Incompatibility (2682)

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

Event Type  malfunction  

Manufacturer Narrative

As the lot numbers for the 67 malfunctions were not provided, a lot history review could not be performed.Out of the 67 reported malfunctions, no devices were returned to the manufacturer for evaluation; therefore, the investigation is inconclusive due to no sample return.The definitive root cause for the reported events is unknown.The devices are labeled for single use.

Event Description

This report summarizes 67 malfunctions.A review of the reported information indicated that model unknown g2 vena cava filter allegedly experienced patient-device incompatibility, migration or expulsion of device, and difficult to remove.This information was received from one source.Out of the 67 reported malfunctions, all involved patients with no patient consequences.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: as the lot numbers for the 67 malfunctions were not provided, a lot history review could not be performed.Out of the 67 reported malfunctions, no devices were returned to the manufacturer for evaluation; therefore, the investigation is inconclusive due to no sample return.The definitive root cause for the reported events is unknown.The devices are labeled for single use.Raman uberoi, charles ross tapping, nicholas chalmers, victoria allgar (2013).British society of interventional radiology (bsir) inferior vena cava (ivc) filter registry.Cardiovasc intervent radiol, 36:1548¿1561.Doi: 10.1007/s00270-013-0606-2.H10: g3.H11: g1, h6(conclusion).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 67 malfunctions.A review of the reported information indicated that model unknown g2 vena cava filter allegedly experienced patient-device incompatibility, migration or expulsion of device, and difficult to remove.This information was received from one source.Out of the 67 reported malfunctions, all involved patients with no patient consequences.Age, weight, and gender were not provided.

• Brand Name: G2 FILTER
• 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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9950703
• MDR Text Key: 187407391
• Report Number: 2020394-2020-02630
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKNOWN G2
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1