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

Catalog Number DL900J

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524); Physical Resistance (2578); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been received and an 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, resistance occurred while the filter was being advanced through the delivery sheath and the filter was said to have punctured a hole in the sheath just past the hub and prior to entering the patient.The filter system was exchanged without incident for a new vena cava filter that was prepped and deployed successfully.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was performed.The lot met all release criteria.Visual inspection: the device was returned used.The introducer sheath was received cut in two segments.The filter was returned with the distal portion (legs) inside the sheath hub.The filter arms were expanded and located outside of the hub.The sheath was perforated.No damage was noted to the dilator.The delivery catheter was kinked.No skiving was found inside the storage tube; however, it appeared to be slightly bowed.It is unknown how the delivery catheter became kinked or the storage tube became bowed as this was not reported by the user.Functional/performance evaluation: the filter was removed from the hub.All 6 arms and 6 legs were present and intact.No limbs were crossed.No anomalies were found to the filter.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no images or photos have been made available to the manufacturer.Conclusion:the filter was returned stuck in the introducer sheath hub.The sheath was perforated.The investigation is confirmed for failure to advance and material puncture.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.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.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.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.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5128842
• MDR Text Key: 27696201
• Report Number: 2020394-2015-01667
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: DL900J
• Device Lot Number: GFYG3708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• 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: 51 YR