MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT-68; CATHETER, PERCUTANEOUS

Model Number	REACT-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The react 68 catheter was returned for analysis within a shipping box and within an opened react 68 inner pouch.The react 68 catheter was decontaminated.The react 68 catheter was measured to be within specification.Upon visual examination, no damages or irregularities were found with the react 68 hub or strain relief.The react 68 catheter body was found broken near the distal tip and retained by the inner wire.The tubing material at the broken ends exhibited jagged edges.Inspection of the remainder of the react 68 catheter, apart from the observed break, revealed no other damage or irregularities.The react 68 catheter was flushed, water exited from the broken location.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.However, the exact cause is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that while the react 68 was being advanced into the rhv it bent and fractured.A continuous flush was used.The react 68 was removed and another react 68 was used successfully.No patient injury occurred.

• Brand Name: REACT-68
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8610014
• Report Number: 2029214-2019-00462
• Device Sequence Number: 2294864
• Product Code: DQY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180715
• Number of Events Summarized: 1
• 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): 05/14/2019

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 Expiration Date: 01/31/2021
• Device Model Number: REACT-68
• Device Lot Number: A771663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1