MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 3005188751-2016-00068, 3005334138-2016-00050.During an ablation procedure, a pericardial effusion in the left atrium occurred while ablating on the lateral mitral annulus.The effusion was confirmed by ice imaging and a pericardiocentesis was performed to stabilize the patient.The patient remained in sinus rhythm and remained hemodynamically stable throughout the procedure.There were no performance issues with any sjm device.

Manufacturer Narrative

(b)(4).The results of the investigation concluded the needle shaft had been bent in multiple locations along its length.A review of the device history record was not possible since the batch number was unavailable.The cause of the pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference 3005188751-2016-00068, 3005334138-2016-00050.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5956734
• MDR Text Key: 54937504
• Report Number: 3008452825-2016-00128
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SAFIRE¿ ABLATION CATHETER; SWARTZ¿ INTRODUCER
• Patient Outcome(s): Required Intervention