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

Catalog Number DL950J

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

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 that during a vena cava filter deployment procedure, it was alleged that the filter was difficult to deploy; however, upon deployment, three filter limbs were allegedly crossed.Approximately seven days post filter deployment, the filter was successfully captured and retrieved via a snare.There was no reported patient injury.

Manufacturer Narrative

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 available for evaluation.However, images and photos were provided for review.The provided photos show no anomalies to the filter.The images show three crossed limbs on the filter after deployment.Therefore, based on the provided images the investigation is confirmed for failure to expand.However, the investigation is inconclusive for the alleged deployment issues.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: delivery of the denali 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.Note: it is possible that complications such as those described in the ¿warnings¿, ¿precautions¿, or ¿potential complications¿ sections of this instructions for use may affect the recoverability of the device and result in the clinician¿s decision to have the device remain permanently implanted.Precautions: if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.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.Advance until the black predeployment mark on the pusher is flush with the proximal end of the touhy-borst adapter.The black predeployment mark on the pusher provides a visual cue indicating that the filter is near the end of the sheath.Prior to deployment, verify the location of the filter within the sheath using fluoroscopy and confirm that the filter snare hook is 1cm below the lowest renal or is in the intended location in the inferior vena cava.Firmly grasp the pusher handle.Keep this hand stationary throughout the entire filter release/deployment process.The filter should be positioned at the distal end of the introducer sheath.Under fluoroscopic guidance, hold the pusher handle stationary, (it is recommended to stabilize the hand on a stationary object) and with the other hand draw the touhy-borst adapter, storage tube and introducer sheath assembly back all the way to the handle, unsheathing and releasing the filter.Ensure that there is no slack or bend in the system during the filter release/deployment process.Note: the assembly should be retracted in one smooth, continuous motion.Ensure that the filter is fully deployed.Under fluoroscopic guidance, carefully withdraw the distal tip of the pusher back into the storage tube by firmly holding the touhy-borst adapter, storage tube, and introducer sheath assembly and pulling back on the pusher.Then disconnect the storage tube from the introducer sheath.Potential complications: failure of filter expansion/incomplete expansion.

Event Description

It was reported that during a vena cava filter deployment procedure, it was alleged that the filter was difficult to deploy; however, upon deployment, three filter limbs were allegedly crossed.Approximately seven days post filter deployment, the filter was successfully captured and retrieved via a snare.There was no reported patient injury.

• Brand Name: DENALI JUGULAR 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: 6868945
• MDR Text Key: 86320099
• Report Number: 2020394-2017-01151
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: DL950J
• Device Lot Number: GFBQ3074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 80 YR