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 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the denali filter products that are cleared in the us.The pro code and 510k number for the denali filter products is 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 physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows a section of the touhy-borst adaptor and a section of the filter storage tube.The pusher catheter is seen in the adaptor with the pusher wire completely detached and in the storage tube.The filter can be seen inside the storage tube.Therefore, based on the photo review, failure to advance can be confirmed as the filter was seen inside the storage tube.Also, detachment was identified as the pusher wire was detached.A definitive root cause for the alleged failure to advance and the identified detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 08/2026) 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 an inferior vena cava filter placement procedure via the iliac vein, the filter allegedly met with high resistance during advancement.The procedure was completed by 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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19189185
• MDR Text Key: 341460899
• Report Number: 2020394-2024-00570
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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: GFHV0097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1