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

Catalog Number DL950F

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510 k number for the denali femoral system products are identified.(expiry date: 02/2023).

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to advance.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a filter placement procedure, the device allegedly failed to advance.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 returned to the manufacturer for evaluation.One video was reviewed.The video shows one filter inside the storage tube.The pusher catheter was inserted inside the storage tube and the pusher wire was above the filter.While pushing the pusher catheter, it indicates that the pusher wire was detached from the pusher and that the filter was no advancing.Therefore, based on the video review, the reported failure to advance and pusher wire detachment can be confirmed.One femoral denali filter inside of a filter storage tube that was attached to a pusher was received.It was noted the pusher wire was detached.Filter was removed with mandrel.All the filter limbs were noted to be present and uncrossed.Skiving of the storage tube took place during advancement, bowing was also noted.Therefore, the investigation can be confirmed for failure to advance and detached pusher wire based on the returned condition of the device and provided video.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali femoral system products that are cleared in the us.The pro code and 510 k number for the denali femoral system products are identified in d2 and g4.H10: d4 (expiry date: 02/2023), h11: h6 (result and conclusion).H11: section a through f ¿ the information provide by bd represents all 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 : see h10.

• 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: 11523624
• MDR Text Key: 240942816
• Report Number: 2020394-2021-00604
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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: GFEP2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 72