MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81531
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Defective curve couldn't place catheter in the coronary sinus.Different catheter opened and used without problem.

• Brand Name: INQUIRY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11626833
• Report Number: 11626833
• Device Sequence Number: 3396656
• Product Code: DRF
• UDI-Device Identifier: 05414734304788
• UDI-Public: (01)05414734304788(17)231130(10)7759606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/02/2021
• Report Date (Section F): 04/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: IBI-81531
• Device Catalogue Number: IBI-81531
• Device Lot Number: 7759606
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 63
• Date Report Sent to FDA: 04/06/2021