MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. A ST. JUDE MEDICAL CO. INQUIRY STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81404

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Device was not the device as described on the outer packaging.Different shape.Not used on patient.

• Brand Name: INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC. A ST. JUDE MEDICAL CO.; 2375 morse avenue; irvine CA 92614
• MDR Report Key: 12347533
• MDR Text Key: 267438318
• Report Number: 12347533
• 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: 08/17/2021

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: No Information
• Device Model Number: IBI-81404
• Device Catalogue Number: IBI-81404
• Device Lot Number: 7886859
• 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: 08/17/2021
• Date Report to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA