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

Model Number	512040-002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Guidewire was examined under microscopy.The device failed at the distal end of the midjoint.The end view shows the corewire fractured with indications of work hardening due to repeated directional bending.The device was measured dimensionally and met all specification requirements, including diameter and bond lengths.The guidewire was used in a calcified lesion that appeared to be a chronic total occlusion, which is contraindicated.The mechanical forces required to cause fracture are substantial.A combination of patient and procedural factors appear to have caused or contributed to this event.The type of lesion made the distal placement of a guidewire unusually difficult.This unfortunate combination of factors led to the fracture.
Event or Problem Description
Guidewire fractured at the junction point between the radiopaque and the non-radiopaque parts.During guidewire manipulation there was no unusual resistance.The fracture was noticed at the time of guidewire withdrawal.Cabg procedure was performed due to failed pci.

• Brand Name: GALEO PRO F CORONARY GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• MDR Report Key: 6037616
• Report Number: 1223414-2016-00003
• Device Sequence Number: 13808109
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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: 02/28/2021
• Device Model Number: 512040-002
• Device Catalogue Number: 389783
• Device Lot Number: 58000716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• 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: GUIDING CATHETER; INTRODUCER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR