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

Model Number	MVP-9Q
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/1974
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mvp has not been returned.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.Mdrs related to this event: 3007170829-2019-00014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of mvp-9q unintentional detachment immediately after being pushed out of the catheter.This event occurred during the treatment of an internal iliac vessel.The devices were prepared and used per the instructions for use (ifu).The vessel size was 7mm, the customer worked cross-over.The device was prepped per ifu but continuous flush was not used.The pushwire was not intentionally rotated when the event occurred.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway, ste. 167; irvine CA 92618
• MDR Report Key: 9373813
• Report Number: 3007170829-2019-00013
• Device Sequence Number: 3067276
• Product Code: KRD
• UDI-Device Identifier: 00847536027732
• UDI-Public: 00847536027732
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: 07/28/2021
• Device Model Number: MVP-9Q
• Device Lot Number: A886731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1