MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR REACT 71 CATHETER; CATHETER, PERCUTANEOUS

Model Number	REACT-68
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual examination, no damages or irregularities were found with the react 68 hub.The react 68 catheter body was found separated at ~77.7cm 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 that when the react catheter was removed from the hoop it was noticed that the catheter was fractured at about the mid point.The tech was certain that catheter was not damaged during handling by lab staff in preparation for the case.There was no allegation of damaging to the inner or outer package of the device.No patient injury occurred.

• Brand Name: REACT 71 CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8202861
• Report Number: 2029214-2018-01090
• Device Sequence Number: 19260030
• Product Code: DQY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: 10/11/2020
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: A725430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1