MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 82 CM SHEATH, LARGE CURL, 8.5F; INTRODUCER, CATHETER

Model Number	G408332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of an 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 effusion 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 manufacturer report number: 3008452825-2018-00342, 3005334138-2018-00343.During an atrial flutter and fibrillation procedure, a pericardial effusion occurred.Immediately following the second transeptal puncture when the ablation catheter was inserted into the sheath the patient became hypotensive.An echocardiogram revealed a pericardial effusion for which a protamine injection and pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 82 CM SHEATH, LARGE CURL, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7931005
• Report Number: 2182269-2018-00123
• Device Sequence Number: 19316816
• Product Code: DYB
• UDI-Device Identifier: 05414734217972
• UDI-Public: 05414734217972
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110450
• 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): 10/03/2018

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: 11/30/2020
• Device Model Number: G408332
• Device Lot Number: 6255292
• 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: 09/17/2018
• Initial Report FDA Received Date: 10/03/2018
• 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: BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR