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

Catalog Number DL950F

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 05/19/2022

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, a photo was provided for review.The investigation of the reported event is currently underway.Expiration date: 04/2023.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 an ultrasound-guided vena cava filter placement procedure via femoral vein, the filter allegedly failed to advance.It was further reported that tear was noted in the sheath.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during an ultrasound-guided vena cava filter placement procedure via femoral vein, the filter allegedly failed to advance.It was further reported that tear was noted in the sheath.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.One photo was provided and reviewed.Based on the provided photo, it can be confirmed that there is damage to the sheath.However, due to the condition of the photo, it is unclear if the sheath is torn.Therefore, the investigation is inconclusive for the reported puncture in sheath and failure to advance issues as there is no clear evidence.A definitive root cause for the reported failure to advance and material puncture 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 (expiration date: 04/2023), g2, g3, h6(method).H11: b3, h6(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.

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: one denali femoral kit was returned for evaluation.During visual evaluation, filter was inside the storage tube.The distal tip was noted to be deformed.The pusher wire was noted to be bent.The introducer sheath was also noted to be kinked.Using mandrel the filter was pushed out of the introducer sheath.Skiving was noted to the storage tube due to advancement of the filter.Introducer sheath and hub was noted to be detached.One photo was provided and reviewed.Based on the provided photo, it can be confirmed that there is damage to the sheath.However, due to the condition of the photo, it is unclear if the sheath is torn.Therefore, the investigation is inconclusive for the reported puncture in sheath and failure to advance issues as there is no clear evidence.Based on these findings the investigation is confirmed for the reported failure to advance issue as the filter was received inside the storage tube and skiving was noted to the storage tube.The investigation is confirmed for the material deformation issue as the introducer sheath was noted to be kinked.The investigation is confirmed for the deformation due to compressive stress issue as the distal tip of the dilator was noted to be deformed.The investigation is confirmed for the material bent issue as the pusher wire was noted to be bent.The investigation is confirmed for the detachment issue as the introducer sheath was noted to be detached for the hub.However, the investigation is unconfirmed for the material puncture issue as there is no puncture was noted to the introducer sheath.A definitive root cause for the reported failure to advance and material puncture and identified material deformation, material bent, detachment of device or device component and deformation due to compressive stress 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.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 an ultrasound-guided vena cava filter placement procedure via femoral vein, the filter allegedly failed to advance.It was further reported that tear was noted in the sheath.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: 14850024
• MDR Text Key: 295796738
• Report Number: 2020394-2022-00523
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

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: GFER1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 11/10/2022
• Supplement Dates FDA Received: 08/26/2022; 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 77 YR
• Patient Sex: Male