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

Catalog Number UNK DENALI

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model unk denali vena cava filter allegedly experienced positioning problem and delayed positioning.The information was received from a single source.One patient was involved with no reported patient.Age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model unk denali vena cava filter allegedly experienced positioning failure.The information was received from a single source.One patient was involved with no reported patient.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive for positioning failure.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4, h6 (device, method).H11: h2.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: DENALI FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10304082
• MDR Text Key: 199836545
• Report Number: 2020394-2020-04766
• 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: 10/19/2020

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: UNK DENALI
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1