MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL

Catalog Number MD800F

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

It was reported that during a vena cava deployment procedure, a kink was discovered at the access site.The filter could not be advanced through the deployment sheath.Therefore, the deployment system and filter were exchanged over the guide wire for a new filter system that was prepped and deployed successfully.There was no reported patient injury.

Manufacturer Narrative

The lot number has been provided and the device history records are being reviewed.The investigation is currently underway.

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the 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 complaint reported to date for this failure mode.The device was returned.No kinks were identified along the length of the introducer sheath, therefore, the investigation is unconfirmed for a kinked sheath.The investigation is inconclusive for failure to advance as the original conditions of use could not be created.However, it should be noted that the filter was able to deploy successfully under laboratory conditions.No images were provided for review.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The current ifu (instructions for use) states warnings/precautions: delivery of the meridian filter through the introducer sheath is advance only.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.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.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.The file was documented with patient and device codes, but not reported.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The report source did not have any additional details to provide at this time.(b)(4).

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• 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 2045
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4668957
• MDR Text Key: 18892869
• Report Number: 2020394-2015-00158
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: MD800F
• Device Lot Number: GFYG3498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR