MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RF400F

Catalog Number RF400F

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported that during a vena cava filter deployment procedure, the filter remained inside the sheath and could not be deployed.A new access site was gained as another filter 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.

• Brand Name: RF400F
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804 204
• Manufacturer Contact: bryan vogel ; 1625 west 3rd st; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4538139
• MDR Text Key: 5354057
• Report Number: 2020394-2015-00066
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K080668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

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: 06/30/2016
• Device Catalogue Number: RF400F
• Device Lot Number: GFXE3339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Patient Age: 54 YR
• Patient Weight: 62