MAUDE Adverse Event Report: CONCERT MEDICAL GALEO PRO; CORONARY GUIDEWIRE

Model Number	389784
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned device was observed to have a 36.6 cm long ptfe scrape in the middle of the guidewire extending to either side of the shaft markers.More ptfe was removed from the proximal end of the wire.Towards the distal end, the ptfe scrape was observed to be a thin line.When examined under magnification, a bend/kink and exposed metal was seen on the guidewire shaft and scratch lines were visible where the ptfe had been scraped off.Guidewire assembly and ptfe coating batch record reviews found no anomalies.The undamaged portion of the device passed the coating adhesion test.The scrape appears to have been caused by mechanical abrasion during the clinical procedure.
Event or Problem Description
Physician reported that, during angioplasty, after withdrawing, he saw a coating delamination and small greenish fragments and mentioned that there might be a potential embolization risk for the patient.Physician reported that the patient was discharged home and had no other event as of (b)(6) 2020.Procedure took place in brazil.

• Brand Name: GALEO PRO
• Common Device Name: CORONARY GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL; 77 accord park drive; norwell MA 02061
• MDR Report Key: 11509784
• Report Number: 1223414-2021-00001
• Device Sequence Number: 4455426
• Product Code: DQX
• UDI-Device Identifier: 00814384020284
• UDI-Public: 00814384020284
• 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): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/28/2024
• Device Model Number: 389784
• Device Catalogue Number: 389784
• Device Lot Number: 58009900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR