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

Model Number	512040-002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was observed under magnification.The fractured corewire had a sharp bend proximal to the break.The fracture occurred 6mm distal to the midjoint, where the cross-section is round.The corewire diameters met specification.Work hardening was evident at the break point, due to bending overload.The incident report states that the fracture occurred during withdrawal.The guidewire fragment was removed using a snare.The potential for kinks and other types of guidewire deformations are well-known for all types of coronary guidewires.The galeo pro coronary guidewire instructions for use clearly advises the user to be aware of this possibility, including the following warning statements: "never push, torque, advance, withdraw or auger the guidewire against resistance without first determining the cause of the resistance under fluoroscopy before taking remedial action.Excessive force against resistance may cause damage and/or fracture which may result in separation of the distal tip" and "always pay attention to the free movement of a guidewire in a coronary artery.Do not move a guidewire without observing the resultant tip response".The user is warned to remove the guidewire and the guide catheter as a single unit if strong resistance is encountered or if the guidewire becomes entrapped within the vasculature.Ong the etire length of the guidewire.Although it is unclear from the images whether the galeo pro tip became entrapped in the apparently spasmed portion of the vessel, this could have contributed to the detachment of the guidewire tip.Production records for the manufacturing lot were examined and no failures or anomalies were present.Given the analysis of the wire performed by concert medical confirmed work hardening at the break point, description of the event by the user and the content of the device labeling it is most likely that the guidewire met its design specifications and the cause of this event was operator error (failure to observe warnings provided in the device labeling and to take appropriate actions as recommended in the instructions for use).
Event or Problem Description
Guidewire fractured during withdrawal.Fragment was retrieved using a snare.

• Brand Name: GALEO PRO F CORONARY GUIDEWIRE
• Common Device Name: CORONARY GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• MDR Report Key: 6086047
• Report Number: 1223414-2016-00006
• Device Sequence Number: 611263
• Product Code: DQX
• UDI-Device Identifier: 00814384020215
• UDI-Public: 00814384020215
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2016

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: 03/31/2021
• Device Model Number: 512040-002
• Device Catalogue Number: 389783
• Device Lot Number: 58000779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 11/08/2016
• 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: BALLOON CATHETER; CORONARY STENT; DILATION CATHETER; GOOSENECK SNARE; GUIDEWIRE; GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR