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

Model Number IPN917235

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

This catheter was used for angiograms of the heart.On the 4th injection, the catheter ruptured.Contrast sprayed over the room.The settings for the injector were a rate of 12ml/s, 16ml, 500 psi, and 0.5 rise.Personally assessed product.Catheter lumen had burst, just distal to the catheter connection hub.Significant risk for introduction of air and subsequent air emboli.Communicated concern with manufacturer representative.

• Brand Name: ARROW
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 16918549
• MDR Text Key: 315087301
• Report Number: 16918549
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F23A0035
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Sex: Male