MAUDE Adverse Event Report: ROI CONSOLIDATED SERVICE CENTER (CSC) REGARD BOWL GUIDEWIRE; CARDIAC CATHTERIZATION KIT

Model Number	HT0951
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Did not reach pt.Small particle found in sterile bowl prior to case start.Fda safety report id# (b)(4).

• Brand Name: REGARD BOWL GUIDEWIRE
• Common Device Name: CARDIAC CATHTERIZATION KIT
• Manufacturer (Section D): ROI CONSOLIDATED SERVICE CENTER (CSC)
• MDR Report Key: 8717350
• Report Number: MW5087487
• Device Sequence Number: 1684811
• Product Code: OES
• UDI-Device Identifier: 10326053113984
• UDI-Public: (01)10326053113984(17)200423(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: HT0951
• Device Lot Number: 67666B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1