MAUDE Adverse Event Report: EP TECHNOLOGIES, INC. ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY

Model Number	3805
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were no rpm display.A rotablator rotational atherectomy system console kit was selected for use.During procedure, it was noted that there were no rpm display on the console.The procedure was not completed due to the event.No patient complications were reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• MDR Report Key: 7865092
• Report Number: 2134265-2018-60841
• Device Sequence Number: 19310598
• Product Code: MCX
• UDI-Device Identifier: 08714729719601
• UDI-Public: 08714729719601
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3805
• Device Catalogue Number: 3805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1