MAUDE Adverse Event Report: VOLCANO CORPORATION COMBOWIRE PRESSURE/FLOW GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	9515
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pt info: attempts to obtain patient information have been unsuccessful.No tests/laboratory data available.Other relevant history: no information available.Implant and explant dates(s): the implant or explant dates are not applicable to this device.Concomitant product(s): no information available.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported, after introduction of the manufacturer's device, in a very tortuous vessel, immediate dissection of the cx coronary artery and subsequent occlusion of the cx occurred.It was decided to immediately stent this artery, no measurements were performed.This was possibly due to the combowire.The patient recovered well and has no complaints.This adverse event is being reported because the patient's vessel was dissected while the manufacturer's device was in use and additional intervention was performed.

• Brand Name: COMBOWIRE PRESSURE/FLOW GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8140605
• Report Number: 2939520-2018-00196
• Device Sequence Number: 1579494
• Product Code: DQX
• UDI-Device Identifier: 00184360000334
• UDI-Public: (01)00184360000334(17)191130
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042996
• 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): 11/06/2018

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: 11/30/2019
• Device Model Number: 9515
• Device Catalogue Number: 804670001
• Device Lot Number: 0033 20085619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/06/2018
• 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