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

Model Number DL900F

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The device was not returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 08/2021).The information provided by bard 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 bard.

Event Description

It was reported that during vena cava filter deployment procedure, upon deployment the filter allegedly did not fully expand.It was further reported that the filter was captured and retrieved successfully and a new ivc filter was used and deployed with no issues.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary:the device was not returned for evaluation.Images were provided and reviewed.Based on the provided images, filter legs were crossed at the distal end.Therefore the investigation can be confirmed for partial deployment and failure to expand.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that during vena cava filter deployment procedure, upon deployment the filter allegedly did not fully expand.It was further reported that the filter was captured and retrieved successfully and a new ivc filter was used and deployed with no issues.There was no reported patient injury.

• 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
• MDR Report Key: 7827412
• MDR Text Key: 118884623
• Report Number: 2020394-2018-01593
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFBV2333
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 75