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

Model Number	MVP-9Q
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mvp device was returned for analysis without the catheter used in the event.In addition, the make/model of the catheter was not provided.Therefore, any contributing factors (including inner diameter specification) from the catheter could not be assessed.The mvp pushwire¿s ptfe shrink tubing was found to be crumpled and torn at multiple locations.In addition, the mvp pushwire was found to be bent.The mvp plug was found to be have detached from the pushwire at the detachment zone.The mvp plug was pulled out from within the distal end of the introducer sheath with resistance.The plug was examined and found to be not fully open.The mvp plug was found to be bent at the proximal end with the membrane cover compressed and stuck together.What appears to be dried blood was found on the mvp membrane cover and struts.The mvp distal marker struts were found to be bent.Due to its damaged condition, the mvp device could not be used for resistance testing with an in-house catheter.Based on the device analysis and reported information, the report of ¿mvp stuck in catheter hub¿ could not be confirmed and the cause could not be determined.In this event, it is likely the introducer sheath was not firmly seated in the catheter hub subsequently causing the pushwire to kink and the plug to become bent, prematurely detaching the plug.In addition, as dried blood was found on the mvp device it is likely the rhv around the introducer sheath was under tightened causing a back flow of blood, contributing to difficulty deploying the device.From the damages seen with the returned mvp device (ptfe shrink tubing damage, bent pushwire, bent plug) it appears there was excessive force used.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the plug wasn't able to load into the catheter causing an inability to advance.There were no related patient symptoms.The devices flushed/prepared as indicated per the ifu.Anatomy was not tortuous.Yes, there was damage to the mvp, we believe this to be the cause of the issue.We believe this happened loading the mvp into the catheter.

• 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: 8276131
• Report Number: 2029214-2019-00053
• Device Sequence Number: 11152296
• Product Code: KRD
• UDI-Device Identifier: 00847536027732
• UDI-Public: 00847536027732
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/24/2019

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: 09/28/2019
• Device Model Number: MVP-9Q
• Device Lot Number: A534638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1