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

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

Patient Problem Death (1802)

Event Date 02/02/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported perforation and subsequent death could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturing reference: 2182269-2017-00036, 3005334138-2017-00016,9680001-2017-00015, 2182269-2017-00037, 2182269-2017-00038.During the procedure, a cardiac perforation occurred and the patient subsequently expired.During the procedure, transseptal puncture was performed without fluoroscopy.When placing the ablation catheter, it appeared to be outside of the model through the appendage and the patient became hypotensive and tachycardic.An intracardiac echocardiogram was performed which revealed a perforation.A pericardiocentesis was performed and the procedure continued with the patient heparinized.By the end of the procedure, the patient decompensated requiring cpr and was taken to the or for a pericardial window and expired later that night.There were no performance issues with any sjm device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 6371414
• MDR Text Key: 68752022
• Report Number: 3008452825-2017-00033
• 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
• Report Date: 02/02/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AGILIS INTRODUCER; BRK TRANSSEPTAL NEEDLE; LIVEWIRE EP CATHETER; SWARTZ SL0 INTRODUCER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 100