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

Model Number 407201

Device Problems Kinked (1339); Malposition of Device (2616)

Patient Problems Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 11/09/2015

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure, a cardiac perforation occurred.Transseptal puncture was performed with a brk transseptal needle through an agilis nxt introducer.The agilis nxt introducer appeared to have a kink in the shaft and was replaced; however, it was unknown when the kink occurred.Non-sjm catheters were advanced into the left atrium and geometry was collected but the posterior pulmonary veins were difficult to access.A transesophageal echocardiogram was performed to verify the puncture site and it appeared the transseptal needle had crossed the septum transmurally before exiting into the left atrium.All catheters and introducers were removed and protamine was administered, at which time the patient appeared to have an anaphylactic reaction.The patient became hypotensive and a widening qrs was noted on the ekg.Cpr was performed for a short time and the patient stabilized after administration of steroids, after which the patient was transferred to the icu for observation.The patient was then stable.

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 cardiac perforation was procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference 3005334138-2016-00004.Additional information received indicates the brk transseptal needle was advanced and withdrawn with no issues.It is thought the agilis nxt introducer may have then contributed to the perforation.

• 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 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 1897- 4050; CS 1897-4050
• MDR Report Key: 5276178
• MDR Text Key: 32985017
• Report Number: 3008452825-2015-00112
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 407201
• Device Lot Number: 5114909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2015
• 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): Other