MAUDE Adverse Event Report: TELEFLEX MEDICAL TWIN-PASS DUAL ACCESS CATHETER 3; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 5200

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 03/20/2023

Event Type  Other  

Event Description

While performing a left heart cath/ selective coronary stent implant.Cardiologist tried to utilized the twin pass dual access catheter device.The device would not allow him to reinsert the wire into the catheter system.He noticed the tip broke off.This happen outside the patient's body.No harm to patient.Teleflex rep notified.

• Brand Name: TWIN-PASS DUAL ACCESS CATHETER 3
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 16645781
• MDR Text Key: 312542498
• Report Number: MW5116134
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2024
• Device Catalogue Number: 5200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1