MAUDE Adverse Event Report: CONCERT MEDICAL, LLC GALEO PRO ES-F CORONARY GUIDEWIRE

Model Number	512040-006
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	10/10/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the device could not be performed as it was not returned.Fluoroscopic videos from a cd-rom showed the device in the artery and the artery showed good flow.After the device was withdrawn, the artery showed poor fllow.This was consistent with the "total occlusion" described in the complaint notification form.In the images the device was not shown in motion, so no evaluation can be made about the user's handling.Images of the guidewire showed nothing remarkable.It appeared to be without kinks or bends, so there was no obvious device-related cause for the total occlusion.The complaint notification form stated that the physician treated the total occlusion with an aspiration catheter and two more stents.The patient was eventually discharged home.
Event or Problem Description
The galeo pro guidewire was used to cross two stenoses in the lad.During withdrawal of the guidewire a total occlusion of the lad occurred.The physician used an aspiration catheter and two more stents for this occlusion.The physician thinks the 4 guidewire was the trigger for the thrombus.

• Brand Name: GALEO PRO ES-F CORONARY GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• MDR Report Key: 6037610
• Report Number: 1223414-2016-00001
• Device Sequence Number: 16230210
• Product Code: DQX
• UDI-Device Identifier: 00814384020253
• UDI-Public: 00814384020253
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2016

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: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: 512040-006
• Device Catalogue Number: 389787
• Device Lot Number: 00570792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2013
• Initial Report FDA Received Date: 10/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR INTRODUCER SHEATH; ASPIRATION CATHETER; BALLOON CATHETER; CORONARY STENTS; GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR