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

Model Number IPN923527

Device Problems Inflation Problem (1310); Failure to Deflate (4060)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

Mid 70¿s male with history of heart failure, chronic kidney disease stage iii and recent shortness of breath.Procedure: right heart catheterization.When the arrow- balloon wedge pressure catheter was used, only part of the balloon would inflate, then it would not deflate properly.No known harm to patient but did delay case.Manufacturer response for arrow- balloon wedge pressure catheter, (brand not provided) (per site reporter).Will obtain.

• Brand Name: ARROW
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 15470159
• MDR Text Key: 300453641
• Report Number: 15470159
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 0801902206746
• UDI-Public: (01)0801902206746(17)231031(01)16F22E0079
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Male
• Patient Weight: 67 KG