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

Model Number	89000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Attempts to obtain patient information have been unsuccessful.Attempts 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.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported for a therapeutic procedure, prior to the procedure, the user plugged in manufacturer's catheter device and received no image.A second catheter device of same was pulled and had the same issue no image (case #(b)(4)).At this point the doctor aborted the case.There was no harm to patient.The returned device was received damaged.Visual and microscopic inspection and functional testing were performed on the returned device.The proximal shaft of the returned device was separated at 655mm distal to the distal telescope strain relief.The shaft was slightly flattened at the break, indicating the shaft was kinked prior to the separation.The exposed drive cable was also kinked.A capacitance test was performed and the device failed.The capacitance was unstable to measure.No additional testing beyond the capacitance test was able to be performed due to the kink and shaft separation.The reported failure could not be duplicated.Device manipulation, impact and applied pressure during use can affect the integrity of the device.Unfortunately, we could not conclusively determine when or how the damage occurred.The instructions for use (ifu) cautions warns use of the device catheter is restricted to cardiovascular specialists who are familiar with, and have been trained to perform, the procedures for which this device is intended.It also warns to not advance the catheter if resistance is encountered.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis the ifu further cautions the device is a delicate scientific instrument and should be treated as such.- clean guide wire and flush catheter thoroughly with sterile heparinized normal saline before and after each insertion.- do not attempt to connect the catheter to electronic equipment other than the designated systems.- never attempt to attach or detach the catheter while the pim motor is running.To do so may damage the connector.- avoid any sharp bends, pinching, or crushing of the catheter.- do not kink or sharply bend the catheter at any time.This can cause drive cable failure.Do not insert the catheter into a guide catheter at an insertion angle greater than 45°.Do not use any catheter that has been kinked or sharply bent.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.This event is being reported because there is a potential for harm if the event were to recur as the shaft separation occurred in a location that enters the body.

• 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: 6664942
• Report Number: 2939520-2017-00059
• Device Sequence Number: 13946245
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)180228
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/12/2017

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: 02/28/2018
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50093017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1