MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number 407201

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 3005188751-2016-00005, 9680001-2016-00014, 3005188751-2016-00006, 3005334138-2016-00008.During a left-side atrial tachycardia ablation procedure, a pericardial effusion occurred.A livewire duo-decapolar catheter was placed in the coronary sinus and an unknown sjm jsn catheter was placed in right ventricle.A transseptal puncture was performed with a brk transseptal needle through a fast cath swartz introducer.At this time, a small pericardial effusion was noted; however, no intervention was performed and it was decided to monitor the effusion throughout the procedure.A tacticath quartz ablation catheter was advanced into the left atrium to begin mapping the atrial tachycardia but was then replaced with a reflexion spiral catheter.Once geometry was completed the patient became increasingly hypotensive and the patient was prepped for a pericardiocentesis due to the pericardial effusion.A cardioversion was performed prior to the pericardiocentesis; however, the patient became asystolic and cpr was administered.The patient rhythm exhibited pulseless electrical activity at one point and the pericardiocentesis was eventually successful, which stabilized the patient.The patient was awake and alert the next day.There were no performance issues with any sjm device during the procedure.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• 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: 5439342
• MDR Text Key: 38281749
• Report Number: 3008452825-2016-00016
• 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: 01/21/2016

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: 407201
• Device Lot Number: 5021191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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
• Patient Outcome(s): Required Intervention