MAUDE Adverse Event Report: VOLCANO CORPORATION REVOLUTION 45MHZ IVUS IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempt to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.No tests/laboratory data was available.No information was available.The implant or explant dates are not applicable to this device.It is unknown if there was any patient harm or event.This is being reported in an abundance of caution.No physical product investigation was possible as the device was infectious and discarded at the facility.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.
Event or Problem Description
It was reported during insertion prior to cross the lesion inside the body the image disappeared.The catheter and the pimr were reconnected to the pimr and the system, and the system was rebooted but the problem was not solved.The patient condition was suddenly changed and the procedure was aborted.This event is being reported in an abundance of caution as by report the patient's condition changed suddenly and procedure was aborted.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.The adverse event experienced by the patient was noted as a ventricular tachycardia (vt).The cause of the vt is undetermined.Additional information provided indicates the event occurred when the manufacturer's device was outside of the patients vasculature while troubleshooting for the lost image.The vt was treated with medication and the patient was discharged as expected in "stable" condition.The case was delayed for approximately 10 minutes.
Event or Problem Description
This follow-up report is being submitted as new information was obtained regarding the procedure.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 6695636
• Report Number: 2939520-2017-00065
• Device Sequence Number: 998934
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)180430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080891
• 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,Followup
• Report Date (Section B): 06/08/2017

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: 04/30/2018
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50098999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/04/2017
• 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: Other