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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT 71 CATHETER; CATHETER, PERCUTANEOUS
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MICRO THERAPEUTICS, INC. DBA EV3 REACT 71 CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number REACT-71
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 02/25/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received a report that the react catheter tip broke off during aspirations and was left in the patient.The piece was non-occlusive and tici result was 2.No additional information was provided at the time of the report.
 
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Brand Name
REACT 71 CATHETER
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key9775268
Report Number2029214-2020-00183
Device Sequence Number2185436
Product Code DQY
UDI-Device Identifier00847536031784
UDI-Public00847536031784
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K182097
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/02/2020
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 Date06/19/2021
Device Model NumberREACT-71
Device Catalogue NumberREACT-71
Device Lot NumberA854030
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2020
Initial Report FDA Received Date03/02/2020
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 Required Intervention;
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