MAUDE Adverse Event Report: COVIDIEN (IRVINE) CATHETER REACT-68; CATHETER, THROMBUS RETRIEVER

Model Number	REACT-68
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Great Vessel Perforation (2152)
Date of Event	10/22/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The react catheter will not be returned for evaluation as it was discarded; therefore, the product analysis cannot be performed.Based on the information provided, there is no evidence suggesting that the device was defective but event is procedure related.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of a vessel perforation during use of a react catheter.The patient was undergoing treatment for an occlusion in the m2 middle cerebral artery (mca).During the procedure, the left internal was accessed using a non-medtronic guidewire.Afterward, the react catheter was delivered wi th a non-medtronic microcatheter inside.A first pass was performed without issue, which aspirated about 50% of the clot.A second pass was attempted.When delivering the react catheter a second time, the catheter became "hung up" on the posterior communicating (pcom) artery, but the physician pushed past the pcom artery.When a run was performed, "rupture" of the pcom artery was observed.It was alleged that the react catheter ruptured the pcom.The patient reportedly passed away intraprocedurally.

• Brand Name: CATHETER REACT-68
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8071856
• Report Number: 2029214-2018-00939
• Device Sequence Number: 1582301
• Product Code: NRY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180705
• 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): 11/14/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: REACT-68
• Device Lot Number: A712607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR