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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED JR. FLOW DIVERTER

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MICROVENTION, INC. FRED JR. FLOW DIVERTER Back to Search Results
Model Number FREDJR2513
Device Problems Separation Failure (2547); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
A search for non-conformance's associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. A video of limited quality was provided, but appears to show the stent deploying proximal to its intended location as described in the complaint. Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed with the device that would have caused or contributed to the reported event.
 
Event Description
It was reported that the fred jr was placed however, removal of the delivery pusher was difficult. Upon withdraw the fred jr. Was released from the delivery pusher, however the stent moved from the desired location. No intervention or harm was reported.
 
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Brand NameFRED JR.
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
7142478000
MDR Report Key12164410
MDR Text Key263459684
Report Number2032493-2021-00283
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFREDJR2513
Device Lot Number19011551W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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