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

Catalog Number UNK DENALI

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation as well as an image and a photo was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that six months post vena cava filter placement, the foreign material was allegedly wrapped around the legs of filter during removal procedure.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation as well as an image and a photo was provided for review.The investigation of the reported event is currently underway.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 six months post vena cava filter placement, the foreign material was allegedly wrapped around the legs of filter during removal procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one denali filter with an unknown snare retrieval sheath was returned for evaluation.Rubber object was noted to be wrapped around filter long legs and caudal legs.Although the sample was returned, one electronic photo and a medial x-ray image were provided and reviewed.Based on the photo review, the photo shows the filter with low resolution and it can be noted the caudal legs of the filter wrapped with rubber and based on the image review, the image quality is poor, no abnormality can be seen to the filter.Per the instruction for use, the retrieval process involves collapsing the filter inside the 9fr retrieval sheath, then withdrawing that whole unit (i.E., the collapsed filter and 9fr retrieval sheath) through the 11fr sheath.If the filter is withdrawn through the 9fr sheath, then damage may be done to the retrieval system, resulting in a ring wrapped around the filter.This can be confirmed with a use related issue on behalf of the retrieval device/procedure.Based on the findings, the investigation is confirmed for the identified improper or incorrect procedure or method issue.The investigation is unconfirmed for the reported device contamination with chemical or other material as the material wrapped on the filter is part of the retrieval system.A definitive root cause for the reported device contamination with chemical or other material and the identified improper or incorrect procedure or method issues could not be determined based upon the provided information.Labeling review: instructions for use reviewed: precaution: the retrieval of the denali filter should only be performed using minimum 9f i.D./11f i.D.Dual retrieval sheaths.Procedural instructions.3.Prepare all other procedure components according to the manufacturers¿ instructions for use.5.Select the appropriate loop diameter size of the intravascular snare.6.Assemble the intravascular snare according to the instructions for use provided by its manufacturer.9.Introduce and advance the 11f retrieval sheath with dilator over the guidewire.10.Remove the 11f dilator.Introduce and advance the 9f retrieval sheath with dilator over the guidewire such that the tip of the sheath is approximately 3cm cephalad to the filter snare hook.11.Remove the guidewire and dilator.12.Insert and advance the intravascular snare assembly through the 9f retrieval sheath until it protrudes out such that the marker band of the snare catheter is cephalad to the filter snare hook.Note: under fluoroscopic guidance, ensure that the loop of the snare has properly engaged the filter snare hook and that the filter snare hook, retrieval sheath and snare are aligned.Be careful to snare the top of the hook; not the side.The marker tip of the snare catheter must be cephalad to the filter snare hook.Note: always maintain tension on the snare to prevent disengagement of the snare loop from the filter snare hook.15.A follow-up venacavogram should be performed prior to withdrawing the 11f retrieval sheath (typically 30ml of contrast medium at 15ml/s).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 six months post vena cava filter placement, the foreign material was allegedly wrapped around the legs of filter during removal procedure.There was no reported patient injury.

• Brand Name: DENALI FILTER 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: 13925788
• MDR Text Key: 288017463
• Report Number: 2020394-2022-00226
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• 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