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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MICROMEWI CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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MICRO THERAPEUTICS, INC. DBA EV3 MICROMEWI CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 41064-01
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not received. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that micrormewi got caught inside of cragg mcnamara and tip dislodged inside of the catheter. It was reported that the physician put the micromewi through a cragg mcnamara. The staff was notified that this usage is off label and probably contributed to the micromewi getting stuck inside. The target location was left middle superficial femoral artery. There were no patient symptoms or complications associated with this event. Instruction for use (ifu) was not followed during preparation, procedure, post-procedure.
 
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Brand NameMICROMEWI
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8424918
MDR Text Key138935076
Report Number2029214-2019-00217
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K940634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2020
Device Model Number41064-01
Device Catalogue Number41064-01
Device Lot NumberA464611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/23/2017
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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