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

Model Number HIGH DENSITY MAPPING CATHETER

Device Problem Break (1069)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Grid catheter sensor broken out of the box, but went inside body before realized.

• Brand Name: ADVISOR HD GRID, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 16494644
• MDR Text Key: 310781426
• Report Number: 16494644
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: (01)05415067028198(17)250930
• 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: 03/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HIGH DENSITY MAPPING CATHETER
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 8729824
• 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: 03/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Male
• Patient Weight: 147 KG
• Patient Race: White