MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. (ST JUDE MEDICAL) INQUIRY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81105

Device Problem Defective Device (2588)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Catheter steering system malfunctioning while in the body.No patient harm.

• Brand Name: INQUIRY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC. (ST JUDE MEDICAL); 2375 morse ave; irvine CA 92614
• MDR Report Key: 15657326
• MDR Text Key: 302252937
• Report Number: 15657326
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302982
• UDI-Public: (01)05414734302982
• 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: 10/19/2022

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: IBI-81105
• Device Catalogue Number: IBI-81105
• 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: 10/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White