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

Catalog Number DL900J

Device Problems Bent (1059); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: all 6 arms and 6 legs were present and intact.Four legs were crossed and held together by the caudal anchors.One arm was bent.It is unknown whether the limb was bent while implanted or bent during retrieval and retraction through the sheath.Dimensional evaluation: the legs were uncrossed and heat was applied.The filter took the appropriate shape.All measurements met the required specifications.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: based on the images provided, the filter legs of a denali filter did not fully expand within the ivc, and some filter legs appearing to be crossed can be confirmed.Based on the photo provided, the investigation is confirmed for crossed filter legs and a bent arm.Conclusion: failure to expand due to several crossed legs can be confirmed.Based on the photo review and returned sample condition, a bent filter arm can be confirmed.Based on the available information, the definitive root cause is unknown.It is unknown if procedural factors 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 at anytime during this procedure; potential complications: failure of filter expansion/incomplete expansion.(b)(4).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, upon deployment the filter limbs were tangled and did not fully expand.The filter was removed and another filter was deployed without incident.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 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: 5581598
• MDR Text Key: 42806251
• Report Number: 2020394-2016-00371
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)181231(10)GFZK3561
• 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: Initial
• Report Date: 03/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: DL900J
• Device Lot Number: GFZK3561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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: 68 YR
• Patient Weight: 100