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

Catalog Number DL950F

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the (b)(4)femoral filter products that are cleared in the us.The 510 k number and pro code for the (b)(4) femoral filter products are identified.Accordingly, this event has been determined to be mdr reportable.No hospital/medical records have been made available to the manufacturer.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.Medical images were provided.The image review and investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported during a vena cava filter deployment procedure, that upon deployment, the filter limbs were caught onto the sheath and caused the filter to deploy at an angle.There are no plans to retrieve the filter at this time.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali femoral filter products that are cleared in the us.The 510 k number and pro code for the denali femoral filter products are identified.Accordingly, this event has been determined to be mdr reportable.Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: the device was not returned for evaluation.However, images were provided and reviewed.Images show one filter tilted within the ivc upon deployment.Therefore the investigation can be confirmed for tilt.The investigation is inconclusive for the alleged deployment issues.Per the reported event details, the pusher wire became entangled with the filter during deployment.The entanglement could have contributed to the angle at which the filter was deployed.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warning: delivery of the filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.Precautions: it is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement.Care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided.Do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher handle at anytime during this procedure.Directions for use implantation: inspect the packaging to ensure that it has not been opened or damaged.Flush the introducer sheath intermittently by hand to maintain introducer sheath patency.Maintaining patency helps prevent clot from interfering with filter deployment.Flush the delivery device with saline through the touhy-borst adapter.Attach the free end of the filter storage tube directly to the introducer sheath already in the vein.The introducer sheath and filter delivery system should be held in a straight line to minimize friction.Loosen the proximal end of the touhy-borst adapter and advance the filter by moving the pusher forward through the introducer sheath.Do not twist or retract the pusher at anytime during the procedure.Potential complications: filter tilt, filter malposition.

Event Description

It was reported during a vena cava filter deployment procedure, that upon deployment, the filter limbs were caught onto the sheath and caused the filter to deploy at an angle.There are no plans to retrieve the filter at this time.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 NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6892734
• MDR Text Key: 88251208
• Report Number: 2020394-2017-01215
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: DL950F
• Device Lot Number: GFAV3101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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