MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ADVISOR HD GRID, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 8650622

Device Problem Failure to Read Input Signal (1581)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

Ep (electrophysiology) catheter, abbott mapping catheter inserted into right groin.Catheter software malfunctioned, would not read.Catheter removed from groin intact.

• Brand Name: ADVISOR HD GRID, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 16385191
• MDR Text Key: 309648704
• Report Number: 16385191
• Device Sequence Number: 1
• Product Code: DRF
• 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: 02/10/2023,02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8650622
• 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: 02/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White