MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. DRAGONFLY OPSTAR; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 1014651

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Catheter read error when connecting, ejected and reconnected, still error.Disconnected after ejecting the 2nd time.

• Brand Name: DRAGONFLY OPSTAR
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2305 walnut street; roseville MN 55113
• MDR Report Key: 11552517
• MDR Text Key: 241748743
• Report Number: 11552517
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)210729(10)7598206
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 7598206
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 85