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

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

Patient Problems Embolus (1830); Hematoma (1884); Cardiac Perforation (2513)

Event Date 06/25/2016

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 cardiac perforation, hematoma, embolus, and thrombosis could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

Related manufacturer reference: 3005334138-2017-00091, 2030404-2017-00028, 3005334138-2017-00092.The following was published in the journal of arrhythmia 33 (2017) 167-171, page 168, 169 and 170.¿the patients were divided into 2 groups, rmn and a man group.A total of 443 patients were included in the study.The rmn group consisted of 214 patients and man group consisted of 229 patients.After pre-procedural transesophageal echocardiograms to exclude left atrial clot, vascular access was obtained via the femoral veins, and multipolar catheters were placed in the coronary sinus and selectively in the right ventricle.Transseptal punctures were performed fluoroscopically and depending on the physician¿s preference, with intracardiac ultrasound guidance.Sw or sl1 sheaths (st jude medical inc., (b)(4), usa) were advanced into the left atrium.Heparin was administered upon left atrial access and an activated clotting time of 250-400s was the target for anticoagulation throughout the procedure.For the man group, ablation was done by standard technique utilizing flexability, tacticath and inquiry optima plus catheters.Both groups had one patient each where the development of pericardia effusions necessitated mid-procedural abandonment, for which they were also considered failed procedures.Among patients in the man group, 2 patients developed significant pericardia effusions during ablation and required emergency pericardiocentesis.The third patient who had tamponade suffered right atrial perforation during difficult trans-septal puncture and was not catheter related.Two patients in the man group suffered significant hematomas prolonging inpatient stay because of difficult groin access, one patient had an intra-procedural air embolism and another patient had a deep vein thrombosis post procedure.The other documented complications included post procedure stroke, access site bleeding with partial thrombosis, and a pulmonary venous infarction from an occluded lingular branch of the pulmonary vein in a patient that presented with hemoptysis.".

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• 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: 6745192
• MDR Text Key: 81091311
• Report Number: 9680001-2017-00052
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• 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: FLEXABILITY; INQUIRY OPTIMA CATHETER; SWARTZ INTRODUCER
• Patient Outcome(s): Required Intervention