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

Model Number 512040-006

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Portions of the ptfe guidewire coating were delaminated in several areas; several bends were also present in the guidewire.This problem is under investigation by the manufacturer.

Event Description

Guidewire would not advance inside guiding catheter.When guidewire was removed from guide catheter the ptfe coating on the guidewire was found to be delaminated in several places.No patient injury or other complications reported.

• Brand Name: GALEO PRO ES-F CORONARY GUIDEWIRE
• Type of Device: CORONARY GUIDEWIRE
• Manufacturer (Section D): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• Manufacturer (Section G): CONCERT MEDICAL, LLC; 77 accord park drive; norwell MA 02061
• Manufacturer Contact: timothy powers ; 77 accord park drive; norwell, MA 02061 ; 7812617407
• MDR Report Key: 6241041
• MDR Text Key: 64553579
• Report Number: 1223414-2017-00001
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00814384020253
• UDI-Public: 00814384020253
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: 512040-006
• Device Catalogue Number: 389787
• Device Lot Number: 00575466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRUISER CORONARY GUIDEWIRE; GUIDING CATHETER
• Patient Outcome(s): Other
• Patient Age: 70 YR