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

Catalog Number MD800F

Device Problems Positioning Failure (1158); Failure to Advance (2524)

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

Event Date 11/05/2012

Event Type  malfunction  

Manufacturer Narrative

After further clinical review, this event has been determined to be mdr reportable pursuant to 21 cfr part 803.The lot number has been provided and the device history records are being reviewed.The investigation is currently underway.

Event Description

It was reported that as the filter was being advanced through the introducer sheath, it became lodged and could not be deployed.The delivery system was removed without incident.Another filter was used to perform the procedure.There was no patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: no medical images have been made available to the manufacturer.Conclusion: the complaint investigation is inconclusive for failure to advance.Based on the available information, a definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/precautions: - 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.- the safety and effectiveness of this device has not been established for morbidly obese patients.- 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.- it is very important to maintain introducer sheath patency with the saline flush so that the grooved segment that holds and properly orients the filter legs does not become covered by clot.

• 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: 4963913
• MDR Text Key: 23156063
• Report Number: 2020394-2015-01274
• 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,health
• Reporter Occupation: Other
• Report Date: 11/05/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: MD800F
• Device Lot Number: GFWE3407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2012
• 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