MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER; VENA CAVA FILTER

Catalog Number MD800F

Device Problems Difficult to Insert (1316); Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Manufacturer Narrative

A further review of this event was performed and identified a change in the mdr reportability pursuant to 21 cfr part 803.Manufacturing review: a lot number was not provided for this device; therefore, a manufacturing review cannot be performed.Visual inspection: unable to perform a visual inspection as the device was not returned.Functional/performance evaluation: unable to perform a functional/performance evaluation as the device was not returned.Medical records review: medical records were not provided.Image/photo review: no images or photos were provided.Conclusion: a lot history review could not be performed as the lot number was not reported.The device was not returned.The complaint investigation is inconclusive for kinked material on the introducer sheath.Based upon the available information, the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: - delivery of the meridian filter through the introducer sheath is advance only.Retraction of the pusher wire during delivery could result in dislodgment of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.- 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.Directions for use: 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 tuohy-borst and advance the filter by moving the nitinol pusher wire forward through the introducer sheath.Do not pull back on the pusher wire, only advance the pusher wire forward.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 could not be advanced to the deployment sheath because the sheath kinked while being advanced into the ivc.A new vena cava filter was prepped and deployed successfully.There is no reported patient injury.

• Brand Name: MERIDIAN FILTER
• 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: 5033757
• MDR Text Key: 24435480
• Report Number: 2020394-2015-01462
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 03/31/2014

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 Catalogue Number: MD800F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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