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

Catalog Number DL950F

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the denali femoral system that are cleared in the us.The pro code and 510 k number for the denali femoral system are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).

Event Description

It was reported that during the procedure, the device allegedly had an expansion issue.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali femoral system that are cleared in the us.The pro code and 510 k number for the denali femoral system are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation, one image and one electronic photo were provided and reviewed.Based on the image review, the provided x-ray image focused primarily on the abdomen.Inferior vena cava filter was seen to the right of the aortic device.The filter does not appear properly expanded.Red marks appear on the image, which likely specified the location of the renal veins during initial deployment of the filter.Based on the photo review, the photo shows the deployed filter being held in hand.The filter appeared to be bloody and entangled filter limbs can be noted to the filter.Therefore, based on the photo review, the reported activation failure including expansion failures could not be confirmed.However, based on the image review the investigation is confirmed for the reported activation failure including expansion failures as it was noted that the filter does not appear properly expanded.A definitive root cause for the reported activation failure including expansion failures could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2024).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.H3 other text : device not returned.

Event Description

It was reported that during the procedure, the device allegedly had an expansion issue.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12329664
• MDR Text Key: 266828419
• Report Number: 2020394-2021-01479
• Device Sequence Number: 1
• Product Code: DTK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2021

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 Catalogue Number: DL950F
• Device Lot Number: GFFP2868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/21/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1