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

Model Number	MVP-7Q
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mvp plug was found to be separated from the pushwire at the detach zone.No bends or kinks were found with the pushwire.No damages were found with the plug proximal marker.No damages were found with the plug membrane.The plug was re-attached to the distal end of the pushwire.The mvp plug was successfully detached from the pushwire with 6 full rotations of the torquer/pusher.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿pre-mature detachment¿ was confirmed, as the mvp plug was found to be separated from the pushwire at the detach zone; however, the root cause could not be determined.No defect was found with the plug or pushwire that would have contributed to the event.In addition, the plug was re-attached and detached from the pusher without issue.It is possible that the plug became detached during handling.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a mvp micro vascular plug that deployed prior to use during surgical prep.The plug deployed during prep.The coil was taken out of the wheel and set it on a table.When they went back to get the plug off of the back table it was noticed that the plug was detached off the wire.There was no harm or injury to the patient.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway, ste. 167,; irvine CA 92618
• MDR Report Key: 9978006
• Report Number: 2029214-2020-00375
• Device Sequence Number: 14015218
• Product Code: HCG
• UDI-Device Identifier: 00847536025431
• UDI-Public: 00847536025431
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: 09/28/2021
• Device Model Number: MVP-7Q
• Device Lot Number: A911859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1