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

Model Number DL900J

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

No device or no medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The 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 post vena cava deployment, during retraction of the introducer sheath, approximately 2cm of the distal tip of the introducer sheath allegedly detached within the patient.It was further reported that the detached segment was captured and retrieved.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were 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.This is the only event reported to date for this lot number and failure mode.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image review: based on the image provided, a semi opaque round cylinder was demonstrated at the location of the right lateral aspect of t1 of the thoracic spine can be confirmed.Based on the image provided, the total length of the semi opaque round cylinder is approximately the same size as the profile of a rib, can be confirmed.Based on the image provided, the removal of the semi opaque round cylinder cannot be confirmed.Photo review: one digital photo was reviewed.One denali label can be seen in the photo.A blue cylindrical object can be identified on the top of the photo.This appears to be consistent with a denali dilator however that cannot be confirmed from the photo.Based on the photo the detached sheath tip cannot be confirmed.Conclusion: the device was not returned.Images were provided.Based on the images provided the investigation was inconclusive for the detached sheath tip.While the round cylinder in the images is most likely a sheath tip, it cannot be confirmed as a denali sheath tip as no photos or samples were provided.It is possible the filter feet embedded in the sheath lumen or engaged on the radiopaque sheath tip during deployment which caused the tip to detach.However, based on the information provided, the definitive root cause was 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.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.Potential complications: detachment of components.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 tuohy-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 tuohy-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.

Event Description

It was reported that post vena cava deployment, during retraction of the introducer sheath, approximately 2cm of the distal tip of the introducer sheath allegedly detached within the patient.It was further reported that the detached segment was captured and retrieved.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were 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.This is the only event reported to date for this lot number and failure mode.Investigation summary: the device was provided for evaluation and images were provided for reviewed.The returned introducer sheath was received in two segments.The material of the sheath near the detachment was noted to be brittle.Based on the provided images and returned sample, the investigation can be confirmed for catheter detachment.Per the evaluation results, the material was noted to be brittle around the point of detachment.Therefore, the brittle material could have contributed to the detachment.The manufacturing site investigated the issue.It is believed that potential exposure to uv light contributed to the material becoming brittle.Based on the returned sample condition and manufacturing investigation the definitive root cause for the issue was unknown.It was unknown when the device could have been exposed to uv light creating the brittle material.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.Potential complications: detachment of components.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.(b)(4).

Event Description

It was reported that post vena cava deployment, during retraction of the introducer sheath, approximately 2cm of the distal tip of the introducer sheath allegedly detached within the patient.It was further reported that surgical intervention was required to capture and retrieve the detached segment.Patient status was unknown.

• 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: 6138879
• MDR Text Key: 61248405
• Report Number: 2020394-2016-01125
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795(17)170531(10)GFYD3270
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFYD3270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; 12/14/2017
• Supplement Dates FDA Received: 02/08/2017; 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• 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 Outcome(s): Required Intervention