MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D402893
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At the beginning of an atrial fibrillation procedure, when mapping was started with the tacticath se and reflexion spiral catheter, an acute pericardial effusion was noted on the ice image.The atrial fibrillation case was begun, transseptal was performed and left atrial mapping geometry commenced.The physician thought the geometry looked odd and asked to see the prior study from (b)(6) 2017.After reviewing that study he returned tableside to continue and noted an effusion on the ice image.The procedure was stopped and a pericardiocentesis was performed.There were multiple perforations on the left side of the heart.The cardiovascular surgeon in house was notified and the patient was eventually taken to have a presumed perforation repaired.The patient was extubated (b)(6) and is stable.There was no alleged issue with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
Additional Manufacturer Narrative
Corrected information: h6.Additional information: g1, g3, h2.

• Brand Name: REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15996391
• Report Number: 2182269-2022-00065
• Device Sequence Number: 20371233
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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: 07/31/2025
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 8532047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 12/01/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/09/2023; 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown