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

Model Number	89001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email and phone.No tests/laboratory data was available.The implant or explant dates are not applicable to this device.No physical product investigation was possible as the device has not been received for analysis.The instructions for use (ifu) warns, do 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 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 the catheter was used for pci (percutaneous coronary intervention).During removal, the proximal shaft separated and the distal part remained inside the body.The distal part was retrieved with a snare.No additional medical or surgical intervention was required.The guidewire and catheter were removed as a system.No damage was observed during prep.The customer noted resistance was encountered.Patient's treatment was completed by the procedure.There was no patient injury.Patient's condition was noted as "stable." vessel: lad#6~#8, occlusion: 90%, tortuousness: severe, calcification: moderate, plaque: mixed this event is being reported as additional intervention was required to remove a portion of the device.

• 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: 6524896
• Report Number: 2939520-2017-00042
• Device Sequence Number: 797380
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)180131
• 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
• Report Date (Section B): 03/27/2017

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: 01/31/2018
• Device Model Number: 89001
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50090682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/26/2017
• 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: Required Intervention