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

Catalog Number DL950F

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the (b)(4) products that are cleared in the us.The pro code and 510k number for the (b)(4) products are identified.(expiry date: 06/2024).

Event Description

It was reported that during a vena cava filter placement procedure and upon reaching the desired location, the filter allegedly failed to deploy.It was further reported that the filter was difficult to be pulled out.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 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: one femoral denali filter kit was returned for evaluation.Received pusher catheter was loaded on to the touhy-borst adapter and connected to the storage tube, and introducer sheath.The introducer was received in two segments.Segment one is having the filter at the distal end.Skiving was noted to the storage tube.Therefore, the investigation is confirmed for failure to advance issue as the filter got stuck inside the sheath and skiving was noted to the storage tube.However, the investigation is inconclusive for the reported failure to deploy as the advancement issue might led to the deployment issue.A definitive root cause for the alleged failure to deploy and identified failure to advance 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.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 vena cava filter placement procedure and upon reaching the desired location, the filter allegedly failed to deploy.It was further reported that the filter was difficult to be pulled out form sheath.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a venacava filter placement procedure and upon reaching the desired location, the filter allegedly failed to deploy.It was further reported that the filter was difficult to be pulled out form sheath.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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: one femoral denali filter kit was returned for evaluation.Received pusher catheter was loaded on to the touhy-borst adapter and connected to the storage tube, and introducer sheath.The introducer was received in two segments.Segment one is having the filter at the distal end.Skiving was noted to the storage tube.Therefore, the investigation is confirmed for failure to advance issue as the filter got stuck inside the sheath and skiving was noted to the storage tube.However, the investigation is inconclusive for the reported failure to deploy as the advancement issue might led to the deployment issue.A definitive root cause for the alleged failure to deploy and identified failure to advance 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: 06/2024), g3.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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13091948
• MDR Text Key: 282833813
• Report Number: 2020394-2021-02118
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• 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,Followup
• Report Date: 01/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: GFFT2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• 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