MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D402865
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.
Event or Problem Description
Related manufacturer reference: 3008452825-2020-00345, 3005334138-2020-00304, 3008452825-2020-00353.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Following ablation of the pulmonary vein, the patient became hypotensive.An echocardiogram confirmed a pericardial effusion.The location and cause of the effusion remains unknown.Protamine was administered and no further intervention was required.There were no further complications and the patient was stabilized.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
Additional information: g4, g7, h2, h3, h6, h10.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 could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10279816
• Report Number: 2182269-2020-00066
• Device Sequence Number: 14106739
• Product Code: DRF
• UDI-Device Identifier: 05414734206211
• UDI-Public: 05414734206211
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072012
• 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,Followup
• Report Date (Section B): 08/14/2020

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: 12/31/2022
• Device Model Number: D402865
• Device Catalogue Number: D402865
• Device Lot Number: 7312999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRK¿ XS TRANSSEPTAL NEEDLE.; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER.; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE.
• Outcome Attributed to Adverse Event: Other