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

Model Number	512040-001
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Large sections of ptfe coating had peeled away from the proximal portion of the device; ptfe coating on distal section of device was still properly adhered.Coating adhesion testing performed with no saline soak confirmed that the ptfe adhesion failed at the proximal section of the guidewire and passed at the distal section.Coating adhesion testing performed after 1 hour saline soak found lack of ptfe adhesion at the proximal and distal end of the device.Review of manufacturing and quality records showed that the manufacturing lot had passed the in-process coating adhesion test.There were no other nonconformities observed for this manufacturing lot.Additional testing will be performed on other samples from the same coating lot if they can be obtained.
Event or Problem Description
During a complex pci just after dilation of the ostium of the lad it was noticed that the ptfe coating of the guidewire had come off of the part of the wire just outside the guiding catheter.While removing the balloon catheter further parts of the coating came loose.No patient injury or additional intervention was required, and the user did not report that any pieces of the coating were left in the patient.The patient was discharged home following completion of the procedure.

• Brand Name: GALEO PRO HF CORONARY GUIDEWIRE
• Common Device Name: CORONARY GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• MDR Report Key: 6044059
• Report Number: 1223414-2016-00004
• Device Sequence Number: 902905
• Product Code: DQX
• UDI-Device Identifier: 00814384020192
• UDI-Public: 00814384020192
• 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): 10/19/2016

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: 05/28/2019
• Device Model Number: 512040-001
• Device Catalogue Number: 389781
• Device Lot Number: 00574827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/20/2016
• 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 GUIDING CATHETER; 6 FR TERUMO INTRODUCER SHEATH; BALLOON CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR