MAUDE Adverse Event Report: REVERSE MEDICAL CORPORATION MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR

Model Number	MVP-9Q
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mvp-9q has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was noted that the physician did 3 small hand puffs of contrast around the plug to check placement and detached within 60-90 seconds, at which point there was little to no cessation of flow upon immediate detachment.They watched the plug and within a minute it migrated further distal down the vessel and lodged against a curve but was not occlusive at all.At the 10 minute mark after migration the plug migrated around a curve landing further in the vessel and was still not occlusive.It is unknown if there were any related patient symptoms.The devices were flushed per the ifu.It was noted that the splenic artery was measured to be 7.2mm.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): REVERSE MEDICAL CORPORATION; 13700 alton parkway, ste. 167; irvine CA 92618
• MDR Report Key: 8495221
• Report Number: 3007170829-2019-00002
• Device Sequence Number: 19240955
• Product Code: KRD
• UDI-Device Identifier: 00847536027732
• UDI-Public: 00847536027732
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: MVP-9Q
• Device Lot Number: A512327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1