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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
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 02/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The catheter has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed and an event cause could not be conclusively determined.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received a report that markers were "left in patient." there is reportedly no further information about the catheter.The patient was undergoing thrombolysis when the event occurred.
 
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Brand Name
MICROMEWI
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key8446767
Report Number2029214-2019-00230
Device Sequence Number19123413
Product Code FOZ
UDI-Device Identifier00847536008038
UDI-Public00847536008038
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K940634
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/22/2021
Device Model Number41064-01
Device Lot NumberA680422
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2019
Initial Report FDA Received Date03/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age56 YR
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