MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER

Model Number	IPN037256
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and new onset of chest pain.Having surgery for coronary artery bypass graft, an a line was inserted.During the surgery, the a-line was unable to be flushed or drew back blood.Removed from patient without known harm.

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11235799
• Report Number: 11235799
• Device Sequence Number: 3843003
• Product Code: DQX
• UDI-Device Identifier: 10801902114041
• UDI-Public: (01)10801902114041(17)221130(10)13F20F0456
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/22/2021
• Report Date (Section F): 01/22/2021

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: Health Professional
• Device Model Number: IPN037256
• Device Catalogue Number: ASK-04500-AH
• Device Lot Number: 13F20F0456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 01/22/2021