MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW; CATHETER, FLOW DIRECTED

Model Number AI-07136

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

The balloon on the balloon wedge pressure catheter did not fully expand or deflate during the prep of the catheter.The catheter was replaced with a new one - no harm to the patient.Manufacturer response for balloon, balloon wedge pressure catheter (per site reporter).Per rl, site notified manufacturer.Similar reports in maude.

• Brand Name: ARROW
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 16113317
• MDR Text Key: 306882453
• Report Number: 16113317
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AI-07136
• Device Lot Number: 16F22E0091
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1