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

Model Number IPN915244

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 9932926
• MDR Text Key: 186704503
• Report Number: 9932926
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902160529
• UDI-Public: 0110801902160529
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915244
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F20B0022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA