MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407453

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/30/2014

Event Type  Injury  

Event Description

Related manufacturer reference 3005188751-2014-00127, 3005188751-2014-00128, 3005188751-2014-00129, 2030404-2014-00097.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Two transseptal punctures were completed using a brk needle and a swartz braided transseptal introducer.The introducer was exchanged with an agilis nxt introducer, through which a safire blu duo ablation catheter was advanced into the left atrium.A reflexion spiral ep catheter was also advanced into the left atrium.The patient became hypotensive and a pericardial effusion was noted via a non-sjm ice catheter.The procedure was stopped and a pericardiocentesis was performed, which stabilized the patient.Once the patient was stable, a cavotricuspid isthmus line ablation was performed.The patient remained stable and was transferred to the icu for observation.There were no performance issues with any sjm device.

Manufacturer Narrative

Additional information: 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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4197483
• MDR Text Key: 5147341
• Report Number: 3005188751-2014-00130
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 407453
• Device Lot Number: 4621174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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: BRK TRANSSEPTAL NEEDLE; REFLEXION SPIRAL EP CATHETER; AGILIS NXT INTRODUCER; SAFIRE BLU DUO ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100