MAUDE Adverse Event Report: VENUSA DE MEXICO S.A. DE C.V. TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 075

Device Problem Insufficient Information (3190)

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

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed and the tacticath quartz ablation catheter was advanced into the left atrium and ablation was initiated.After approximately one hour, the patient became hypotensive and an echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient and the procedure was stopped.There were no alleged performance issues with any sjm devices.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactics quartz system were returned.Review of the log files revealed the device functioned as intended and there were no contributing anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The cause of the reported pericardial effusion may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): VENUSA DE MEXICO S.A. DE C.V.; calle hertz 1525-6; parque industrial j. bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer (Section G): VENUSA DE MEXICO S.A. DE C.V.; calle hertz 1525-6; parque industrial j. bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5138489
• MDR Text Key: 27907076
• Report Number: 9680001-2015-00016
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2016
• Device Model Number: PN-004 075
• Device Catalogue Number: PN-004 075
• Device Lot Number: 4731985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 107