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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1610090
Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that when manipulating the cello balloon catheter on the operating table, there was a leak at the hub of the catheter where the balloon is inflated, and the balloon would not inflate. The leak was oberseved during preparation, and all devices were prepared as per the instructions for use (ifu). There were no patient symptoms or complications with the event. Additional information received on 24-jul-2020 reported that when removing the air from the balloon during preparation it was noticed that the balloon's inflation hub was cracked and leaking liquid, causing the balloon to not inflate. No excessive force was applied when connecting the y connector or syringe to the catheter hub. The guidewire used was hydrophilic stiff. 035, and there was no extensive guidewire manipulation. The guidewire tip was not shaped, and the contrast ratio was. 5 ml of contrast and. 5 ml of serum. The injection rate was slow. The devices were flushed and hydrated according to the instructions for use (ifu).
 
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Brand NameCELLO BALLOON GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10344556
MDR Text Key202370847
Report Number2029214-2020-00749
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2020
Device Model Number1610090
Device Catalogue Number1610090
Device Lot Number1610090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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