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

Catalog Number DL950F

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified 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.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.Expiration date: 02/2025.

Event Description

It was reported that during a filter placement procedure via femoral vein, the delivery rod of the filter was allegedly found to be kinked.It was further reported that the delivery rod was allegedly found to be ruptured.The procedure was completed 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 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.Two electronic photos were provided and reviewed.The first photo shows the pusher catheter, touhy adapter, and filter storage tube.The pusher wire was noted to be twisted and bent.The second photo shows the filter and filter storage tube inside the package.Therefore, the investigation is confirmed for the reported material deformation issue as the pusher wire was noted to be bent and twisted.The investigation is inconclusive for the reported detachment issue as there is no detachment noted in the provided photo and the sample was not returned for evaluation.A definitive root cause for the reported material deformation and detachment issue could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The current instructions for use states that, precaution: do not twist the pusher wire handle at anytime during this procedure.H10: d4 (expiry date: 02/2025), g3.H11: h6 (device, method, result, conclusion).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 a filter placement procedure via femoral vein, the delivery rod of the filter was allegedly found to be kinked.It was further reported that the delivery rod was allegedly found to be ruptured.The procedure was completed 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: 15578450
• MDR Text Key: 305635618
• Report Number: 2020394-2022-00792
• Device Sequence Number: 1
• Product Code: DTK
• 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: 12/14/2022

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: GFGP1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/28/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female