MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE ADVISOR

Model Number D-AVSE-DF10-F15

Device Problems Difficult to Remove (1528); Sticking (1597); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 10/13/2017

Event Type  Injury  

Event Description

St.Jude advisor catheter became twisted and stuck upon itself in the left atrium once crossed through transeptal approach.The md spent 20 minutes trying to untwist the catheter.Length of procedure increased with anesthesia.Heart team notified in case catheter needed to be surgically removed.

• Brand Name: ST. JUDE ADVISOR
• Type of Device: ST. JUDE ADVISOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 7224511
• MDR Text Key: 98549283
• Report Number: MW5074920
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D-AVSE-DF10-F15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization