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

Model Number	5913190
Medical Device Problem Codes	Obstruction of Flow (2423); Malposition of Device (2616)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes three malfunction events.A review of the events indicated that model ec500f eclipse filter system experienced a malposition of device.These reports were received from various sources.For each event, a patient was involved, but there was no reported injury.Age and weight were not provided for any of the complaints.In one case, the patient was male.In the other two cases, sex was not provided.None of the ec500f eclipse filter system were returned, limiting investigation.
Event or Problem Description
This report summarizes three malfunction events.A review of the events indicated that model ec500f eclipse filter system experienced a malposition of device.These reports were received from various sources.For each event, a patient was involved, but there was no reported injury.Age and weight were not provided for any of the complaints.In one case, the patient was male.In the other two cases, sex was not provided.
Additional Manufacturer Narrative
H10: the lot number for two of the malfunctions were provided and a lot history review was performed; the lot umber for the third malfunction was not provided.The devices have not been returned for evaluation; therefore, the investigations are inconclusive for malposition (tilt) of device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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.
Additional Manufacturer Narrative
H10: the lot number for three of the malfunctions were provided and a lot history review was performed.The devices have not been returned for evaluation; however, medical records were provided for two malfunctions.The review of the medical records identified that the investigation is inconclusive for malposition of the device.One of the malfunctions was reassessed and trending device code (2423 ¿ occlusion) has been added.For remaining malfunction, the investigations are inconclusive for malposition (tilt) of device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The devices was labeled for single use.H11: b5, d4 (lot number), g1, h6 (device code - 2423 - occlusion).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 or Problem Description
This report summarizes three malfunction events.A review of the events indicated that model ec500f eclipse filter system experienced a malposition of device.These reports were received from various sources.All three events had no reported patient injury.Of the three reported patient, 2 patients were male, one patient weight was 267 lbs; however, other patients age, weight and gender were not provided.
Event or Problem Description
This report summarizes two malfunctions.A review of the events indicated that model ec500f eclipse filter system experienced a malposition of device.These reports were received from various sources.Both the events had no reported patient injury.Of the reported events both the patients' were male and one weighs 267 lbs.The remaining patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number were provided for both the malfunctions and the lot history review was performed.The devices have not been returned for evaluation; however, medical records were provided for both the malfunctions.The investigations are inconclusive for the reported malposition of device.Additionally one malfunction was reassessed to have 2423 ¿ occlusion and it is inconclusive based on the investigation.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.H10: one malfunction was reassessed for reportability and determined to be reportable as a serious injury, and were reported under emdr 2020394-2020-05377.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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model ec500f vena cava filter experienced malposition of device and obstruction of flow.The information was received from a one source.This malfunction involved one patient with no patient consequences.A male patient weighs 267 lbs.Age of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided, therefore a lot history review was performed.The device was not returned for evaluation.Medical records were provided and reviewed.Therefore, the investigation is inconclusive for filter tilt and occlusion.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: two malfunctions were reassessed for reportability and determined to be reportable as a serious injury, and were reported under emdr 2020394-2020-05377 and 2020394-2022-90089.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.

• Brand Name: ECLIPSE FILTER SYSTEM
• Common Device Name: 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: 8521072
• Report Number: 2020394-2019-00380
• Device Sequence Number: 11131424
• Product Code: DTK
• UDI-Device Identifier: 00801741013836
• UDI-Public: (01)00801741013836
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/13/2022

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 Model Number: 5913190
• Device Catalogue Number: EC500F
• Device Lot Number: GFUI2732
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019; 03/24/2020; 09/30/2020; 03/31/2022
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/25/2019; 04/01/2020; 10/23/2020; 04/13/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown