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

Catalog Number DL950J

Device Problem Material Deformation (2976)

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

Event Date 01/11/2024

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 products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2025) h11: section a through f ¿ the information provided 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 : device not returned.

Event Description

It was reported that during an inferior vena cava filter placement procedure, the leg of the filter was allegedly bent inward.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during an inferior vena cava filter placement procedure, the leg of the filter was allegedly found to be bent inward.The procedure was completed by 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 products that are cleared in the us.The pro code and 510 k number for the denali products 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 physical sample was not returned for evaluation.Seven photos were provided and reviewed.The first and second photo shows the storage tube with filter.The third, fourth, fifth, sixth and seventh photo shows that the leg of the filter is bent inward.Therefore, based on the photo review the reported material deformation can be confirmed.A definitive root cause for the alleged material deformation 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: 07/2025), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f ¿ the information provided 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.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 18639206
• MDR Text Key: 334505376
• Report Number: 2020394-2024-00164
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL950J
• Device Lot Number: GFGV1207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• 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