MAUDE Adverse Event Report: REVERSE MEDICAL CORPORATION MICRO VASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number MVP-3 US

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 10/02/2013

Event Type  malfunction  

Manufacturer Narrative

The review of device history records did not demonstrate any non-conformities that could lead to the field complaint.The one device was returned for device investigation.The membrane was skirted around the middle of the device.It could not be determined the amount of adhesive present on the membrane at the proximal marker band.Three units from the same lot were taken from inventory and were reviewed under the m microscope.The sheath has uneven cuts but did not hinder resheathing and sheathing forces were still lower than historical data.The amount of glue at the membrane and struts near the proximal marker band appeared to be acceptable.Fatigue testing was performed for the three units and it was determined that there were 30, 60, and 35 resheathing cycles required to cause holes in the membrane.It could not be determined if the detachment of the membrane was due to lack of adhesion of the membrane at the struts near the proximal marker band or if during resheathing, the physician had the mvp device at an angle (instead of straight) which could cause damage to the membrane during resheathing.This report was inadvertently previously filed under the (b)(4) registration number of manufacturing site (mdr# 2029214-2015-002611).As a result we are refiling the report with the correct reverse medical corp manufacturer report number.

Event Description

During review of the micro vascular plug on the preparation table, the mvp was resheathed.The membrane was pushed off the struts and moved to the middle of the device.

• Brand Name: MICRO VASCULAR PLUG
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): REVERSE MEDICAL CORPORATION; 13700 alton parkway; irvine CA 92618
• Manufacturer (Section G): REVERSE MEDICAL CORPORATION; 13700 alton parkway; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5033931
• MDR Text Key: 24799788
• Report Number: 3007170829-2015-00004
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 10/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: MVP-3 US
• Device Lot Number: 13307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2013
• 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