MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F; CATHETER, 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	06/19/2018
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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturing reference: 9680001-2018-00105, 2182269-2018-00091, 3005334138-2018-00209, 3008452825-2018-00237.During a wide area circumferential atrial fibrillation ablation procedure a cardiac perforation occurred.Following dual transseptal access and pulmonary vein ablation a perforation was diagnosed via an ultrasound catheter.A pericardiocentesis was performed to stabilize the patient.The ablation procedure was continued with no further adverse patient consequences.There were no performance issues with any abbott device.

• Brand Name: REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7698131
• Report Number: 2182269-2018-00092
• Device Sequence Number: 1120472
• Product Code: DRF
• UDI-Device Identifier: 05414734206211
• UDI-Public: 05414734206211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 02/28/2021
• Device Model Number: D402865
• Device Lot Number: 6321166
• 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: 06/19/2018
• Initial Report FDA Received Date: 07/18/2018
• 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; BAYLIS TRANSSEPTAL NEEDLE; BOSTON SCIENTIFIC POLARIS X; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER; STRYKER ULTRASOUND CATHETER; SWARTZ¿ BRAIDED INTRODUCER; TACTICATH¿ ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91