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

Catalog Number DL900J

Device Problems Sticking (1597); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/09/2015

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 procedure, the filter became stuck inside the deployment sheath; no attempt was made to deploy the filter.The filter system was exchanged for a new filter that was deployed successfully.There was no reported patient injury.

Manufacturer Narrative

(b)(4).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.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: several kinks were found along the length of the catheter.However, after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kink.No catheter kinks were reported by the user.An indentation was noted approximately 19.9cm from the distal tip.The direction of the indentation is from the inside out and was likely caused by the filter as it was being advanced through the sheath.No other anomalies were noted.Functional/performance evaluation: the sheath was placed inside an x-ray machine.The denali filter was found to be stuck in the sheath just distal to the indentation.A mandrel was used to advance the filter through the sheath.All 6 arms and 6 legs were present and intact.There were no crossed limbs upon deployment.No anomalies were identified.Dimensional evaluation: heat was applied and the filter took the appropriate shape.All measurements met the required specifications.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was returned.The investigation is confirmed for failure to advance as the filter was returned stuck in the introducer sheath.Based upon the available information, the definitive root cause for this event is unknown.It is unknown if procedural factors contributed to the reported event.Labeling review: the denali filter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.(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.

• 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: 5092204
• MDR Text Key: 26606958
• Report Number: 2020394-2015-01625
• 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: 08/28/2015

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: 06/30/2018
• Device Catalogue Number: DL900J
• Device Lot Number: GFZD4289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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: 61 YR
• Patient Weight: 108