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

Catalog Number DL950J

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976); Activation Failure (3270)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during vena cava filter placement via the internal jugular vein, the vena cava filter was allegedly unable to insert through the sheath and the filter was allegedly deformed.It was further reported that another device was used to complete procedure.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 jugular system that are cleared in the us.The pro code and 510 k number for the denali jugular 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: one denali filter kit was returned for evaluation.Following components were received: dilator, pusher catheter, introducer sheath, filter storage tube, touhy-borst adapter and filter.Filter was noted to be extending out of the storage tube with two of the legs crossed and damaged.No skiving or bowing noticed to the storage tube, no damage to the introducer sheath or dilator.Based on the findings, the investigation is confirmed for the reported failure to advance issue as the filter was noted to be extending out of the storage tube.However, the investigation is inconclusive for the reported activation failure including expansion failure as the reported event cannot be reconfirmed.A definitive root cause for the reported failure to advance and activation failure including expansion failure issues 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.

Event Description

It was reported that during vena cava filter placement via the internal jugular vein, the vena cava filter was allegedly unable to advance through the sheath.It was further reported that the filter was allegedly deformed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12493974
• MDR Text Key: 272114428
• Report Number: 2020394-2021-01754
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• 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: 09/24/2021

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: DL950J
• Device Lot Number: GFFQ0658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1