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

Model Number G407208

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/28/2016

Event Type  Injury  

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

Event Description

Related manufacturer: 9680001-2016-00089, 2182269-2016-00027.During an atrial fibrillation procedure a cardiac tamponade occurred.Following isolation of the left pulmonary veins, ablation was performed on the anterior wall of the right superior pulmonary vein.The patient became hypotensive and an echocardiogram revealed a cardiac tamponade.Protamine was administered and the patient was transferred to surgery and a pericardiocentesis was performed.The patient was stable.There were no performance issues with any sjm device.

• Brand Name: BRK¿ XS 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: 6122926
• MDR Text Key: 60744768
• Report Number: 3008452825-2016-00158
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: G407208
• Device Lot Number: 5601044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIOSENSE WEBSTER CATHETER; ELA MEDICAL CATHETER; SWARTZ TRANSSEPTAL INTRODUCER; TACTICATH CATHETER; TERUMO INTRODUCER; TERUMO INTRODUCER; TERUMO INTRODUCER; TERUMO INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75