MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number 407207

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

Patient Problem Cardiac Perforation (2513)

Event Date 08/29/2016

Event Type  Injury  

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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related mfr report numbers: 9680001-2016-00075, 3005188751-2016-00069 and 3005188751-2016-00070.Following completion of a pulmonary vein isolation procedure an effusion was noted.The patient became hypotensive and the perforation was confirmed with ice and a transthoracic echocardiogram.A pericardiocentesis stabilized the patient and the right sided flutter ablation was not completed and the patient was transferred to the unit for observation.There were no performance issues with any sjm devices.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 98 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: 5979401
• MDR Text Key: 55683967
• Report Number: 3008452825-2016-00130
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 407207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• 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 STEERABLE INTRODUCER-408310; AGILIS STEERABLE INTRODUCER-408310; TACTICATH ABLATION CATHETER (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 175