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

Catalog Number DL950J

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported information, the device was returned to bd for evaluation.The evaluation identified detachment.Based on the available information, the definite root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model dl950j vena cava filter allegedly experienced detachment of a filter limb and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The female patient's age and weight were not provided.

• Brand Name: DENALI VENA CAVA 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: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8813630
• MDR Text Key: 151866784
• Report Number: 2020394-2019-01710
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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
• Report Date: 07/22/2019

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: DL950J
• Device Lot Number: GFBY2297
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/22/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1