Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION INC. HYPERSOFT ADVANCED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION INC. HYPERSOFT ADVANCED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 8510-0206
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2022
Event Type  malfunction  
Event Description
Item integrity was tested with electronic deployment device and failed (test indicator light remained red).This has been reported to mfg.Rga# 3002084871, complaint# (b)(4), returned [redacted date], fedex tracking# 278012827417, shipped in no charge replacement product.Manufacturer response for hypersoft 3d microplex 10 coil 2mm x 6cm, (brand not provided) (per site reporter) issued complaint# (b)(4), sending no charge replacements.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HYPERSOFT ADVANCED
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
MICROVENTION INC.
35 enterprise
aliso viejo CA 92656
MDR Report Key16156660
MDR Text Key307275012
Report Number16156660
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/04/2023,09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8510-0206
Device Catalogue Number8510-0206
Device Lot Number0000093548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/04/2023
Event Location Hospital
Date Report to Manufacturer01/13/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24090 DA
Patient SexFemale
-
-