MAUDE Adverse Event Report: DENALI JUGULAR SYSTEM; VENA CAVA FILTER

Model Number DL900J

Device Problem Material Deformation (2976)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

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: 03/2022).

Event Description

It was reported that during a filter placement procedure, the filter leg was allegedly bent upwards.The filter was retrieved from the patient.There was no reported patient injury.

Event Description

It was reported that during a filter placement procedure, the filter leg was allegedly bent after deployment.It was further reported that the filter was retrieved from the patient.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one denali filter kit was returned for evaluation.The following components were received: pusher catheter, touhy-borst adapter, filter storage tube, introducer sheath, dilator, and filter.One filter arm was noted to be bent and damaged.Therefore the investigation is confirmed for material deformation issue as the filter arm was noted to be bent.A definitive root cause for the reported material deformation issue 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: 03/2022).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 : see h10.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• MDR Report Key: 12631182
• MDR Text Key: 276389403
• Report Number: 2020394-2021-01872
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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 Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFDP1365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 117