MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, FLOW DIRECTED

Model Number	IPN923527
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of chronic systolic heart failure.Procedure: right heart catheterization.The balloon of the swan was stuck inflated therefore recording incorrect pressures.Balloon would not deflate.No known harm to patient- another one used without issues.Manufacturer response for catheter, flow directed, arrow (per site reporter) will obtain.

• Brand Name: ARROW
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 19040084
• Report Number: 19040084
• Device Sequence Number: 12580339
• Product Code: DYG
• UDI-Device Identifier: 10801902206746
• UDI-Public: (01)10801902206746(17)250630(10)16F24A0029
• 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): 03/13/2024
• Report Date (Section F): 03/13/2024

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 Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F24A0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 2 KG
• Date Report Sent to FDA: 03/13/2024