MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA REACT 71 CATHETER; CATHETER, PERCUTANEOUS

Model Number	REACT-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The react 68 catheter (model: react-68 lot: a726448) was returned for analysis within a shipping box; within an opened react 68 outer carton and within an opened react 68 inner pouch.The react 68 catheter total length was measured to be ~140.3cm (reference.D: 141cm +3cm) and the useable length was measured to be ~133.6cm which is within specification (specification: 132cm +3/-0cm).Upon visual examination, no damages or irregularities were found with the react 68 hub.The react 68 catheter body was found separated at ~128.4cm from the distal tip, retained by the inner wire.The tubing material of the separated ends exhibited with jagged edges.Inspection of the remainder of the react 68 catheter, apart from the observed separation, revealed no other damage or irregularities.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of react-068 catheter separation during a demonstration.A medtronic employee was at a facility demonstrating use of the solitaire device and react-068 for educational purposes.The medtronic employee reported tying and untying a knot in the 'grey area' of the react.As the react was being moved to the demonstration table, the catheter reportedly "snapped under its own weight" in the green area close to its proximal end.There were no patients involved in this event.

• Brand Name: REACT 71 CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8217572
• Report Number: 2029214-2019-00004
• Device Sequence Number: 1593032
• Product Code: DQY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: A726448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1