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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR
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REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number MVP-9Q
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Physician used a 9q micro vascular plug with a non-medtronic 4fr sheath during a procedure to treat the patient¿s proximal left internal iliac artery.The device was inspected prior to use.Ifu was followed and the device was prepped without issue.It is reported the plug pre-detached in the 4fr sheath.The detachment occurred fully in the sheath.No part of the device remained in the patient.A second 9q micro vascular plug was opened to complete the procedure.No patient injury reported.
 
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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 Key10331200
Report Number3007170829-2020-00007
Device Sequence Number10969162
Product Code KRD
UDI-Device Identifier00847536027732
UDI-Public00847536027732
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K150108
Number of Events Summarized1
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) 07/28/2020
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 Date09/28/2021
Device Model NumberMVP-9Q
Device Catalogue NumberMVP-9Q
Device Lot NumberA919669
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2020
Initial Report FDA Received Date07/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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