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

Catalog Number DL950J

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 jugular deployment of a vena cava filter, the filter legs were allegedly twisted.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the (b)(4) 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.This is the only event reported to date for this lot number and failure mode.Visual inspection: the sample was returned with the product label and packaging.The storage tube and y-body were not returned for evaluation.No anomalies were noted to the returned dilator.A slight kink was noted 54.3 cm from the distal tip of the sheath.The pusher catheter was noted to be kinked 29.2 m from the proximal end of the handle.The kinks will be noted as incidental findings as it is unknown when they occurred as they were not reported by the facility.The filter was returned fully deployed.All 6 arms and 6 legs were present and intact.All of the limbs were fully expanded.Dimensional evaluation: heat was applied to the filter and the filter took the appropriate shape.All measurements met the required specification.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.Images were not provided.Medical records were not provided.The complaint investigation was inconclusive for the reported event as crossed limbs were not observed on the returned filter.Per the reported event, the physician pulled back on the pusher prior to deployment.Per the instructions for use (ifu), "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." therefore, it is possible that the physician's deployment technique contributed to the reported event.Per the reported event, there was clot burden in the area deployed.Therefore, it is possible that patient factors (clot) prevented the filter from completely expanding within the ivc.Labeling review: the current ifu (instructions for use) states: warning: 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: 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.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 jugular deployment of a vena cava filter, the filter legs were allegedly twisted.Reportedly, the health care provider captured and retrieved the filter and successfully deployed another.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: 6187760
• MDR Text Key: 62794624
• Report Number: 2020394-2016-01180
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: DL950J
• Device Lot Number: GFAS2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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
• Patient Age: 66 YR