MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY LUMA-CATH STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81938
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of a pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a crt-d implant procedure, a pericardial effusion occurred.After inserting the catheter via left side access into the coronary sinus and subsequent imaging of the contrast agent via x-ray, a pericardial effusion was identified in the coronary sinus.The catheter was retracted back into the superior vena cava.The pericardial effusion was monitored throughout the procedure and the implant device was placed successfully and the patient left the lab is in stable condition.The physician believed the coronary sinus catheter may have been the reason for the effusion.There were no performance issues with the device.

• Brand Name: INQUIRY LUMA-CATH STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10599286
• Report Number: 2030404-2020-00082
• Device Sequence Number: 3054185
• Product Code: DRF
• UDI-Device Identifier: 05414734306294
• UDI-Public: 05414734306294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K991878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: IBI-81938
• Device Catalogue Number: IBI-81938
• Device Lot Number: 6438111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other