• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA MO.MA ULTRA US; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

  • 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
 

INVATEC SPA MO.MA ULTRA US; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE Back to Search Results
Catalog Number MUS0130069X6
Device Problems Burst Container or Vessel (1074); Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used a moma ultra with a non-medtronic 6fr sheath and a 0.035 non-medtronic guidewire during treatment of a 30 mm lesion in the patient¿s mid right common carotid artery of diameter 8 mm.The ifu was followed and the device was prepped and inflated during prep without issue.It is reported when the common balloon was inflated prior to stenting it burst.The balloon burst when the physician inflated with 8 cc of the contrast/saline mixture per the ifu.No component embolisation occurred.A new moma device was used to successfully complete the procedure.No patient injury was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MO.MA ULTRA US
Type of Device
CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT  25030
MDR Report Key7717421
MDR Text Key115110065
Report Number3004066202-2018-00041
Device Sequence Number1
Product Code NTE
UDI-Device Identifier08033477050140
UDI-Public08033477050140
Combination Product (y/n)N
PMA/PMN Number
K092177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/04/2018
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
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberMUS0130069X6
Device Lot Number1L000677
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/27/2018
Initial Date FDA Received07/25/2018
Supplement Dates Manufacturer Received08/08/2018
Supplement Dates FDA Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-