MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW; CATHETER, FLOW DIRECTED

Model Number	IPN915244
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged female with history of shortness of breath and pulmonary hypertension.Having a heart cath and the swan catheter going to be used for procedure was tested.Balloon inflated but did not deflate for 6 minutes.

• Brand Name: ARROW
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 9932926
• Report Number: 9932926
• Device Sequence Number: 3697455
• Product Code: DYG
• UDI-Device Identifier: 10801902160529
• UDI-Public: 0110801902160529
• 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): 03/31/2020
• Report Date (Section F): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915244
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F20B0022
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/31/2020