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

Model Number IPN037256

Device Problem Flushing Problem (1252)

Patient Problem Chest Pain (1776)

Event Date 01/21/2021

Event Type  malfunction  

Event 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
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11235799
• MDR Text Key: 228888043
• Report Number: 11235799
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 10801902114041
• UDI-Public: (01)10801902114041(17)221130(10)13F20F0456
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN037256
• Device Catalogue Number: ASK-04500-AH
• Device Lot Number: 13F20F0456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 98