MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an inherent risk of any electrode replacement.
Event or Problem Description
Related manufacturing ref: 3005334138-2019-00003, 3008452825-2019-00001, 3005334138-2019-00004, 3008452825-2019-00002.During an atrial fibrillation procedure, a pericardial effusion occurred.The spiral catheter was used to create the geometry but the geometry did not appear correct.An echogram revealed a pericardial effusion on the posterior wall.No ablation had been carried out prior to the effusion.A pericardial drain was used to stabilize the patient.There were no performance issues with any abbott device.

• 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, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8219322
• Report Number: 2182269-2019-00002
• Device Sequence Number: 19230684
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• 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
• Report Date (Section B): 01/04/2019

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: 08/31/2021
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 6558755
• 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: 12/12/2018
• Initial Report FDA Received Date: 01/04/2019
• 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: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; BRK-1¿ XS TRANSSEPTAL NEEDLE; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE CATHETER SENSOR ENABLED¿
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90