MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE)

Model Number NAVISTAR

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

Patient Problems Stroke/CVA (1770); Ischemia (1942)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This complaint is from literature source.One patient (b)(6) female with a prior history of persistent atrial fibrillation, hypertension, diabetes and chads2 score of 6.After the cardiac ablation procedure the patient developed ischemic stroke.The patient had previous cerebrovascular accident in the past.The physician opinion regarding this event is that some embolic events may have been caused by thermally induced blood clots and this phenomenon is totally unresponsive to anticoagulation.There is no claim of malfunction.Article title: "low incidence of permanent complications during catheter ablation for atrial fibrillation using open-irrigated catheters: a (b)(4)" the aim of the present study was to assess the incidence of complications with permanent sequelae of ca for af using open-irrigated catheters in a contemporary, unselected population of consecutive patients.The 2167 patient were enrolled into this study from january 1 and december 31, 2011.From the article other complications were reported: one patient (b)(6) female with a prior history of persistent atrial fibrillation, hypertension and chads2 score of 1.After the cardiac ablation procedure the patient developed ischemic stroke.The physician opinion regarding this event is that some embolic events may have been caused by thermally induced blood clots and this phenomenon is totally unresponsive to anticoagulation.There is no claim of malfunction.

Manufacturer Narrative

(b)(4).One patient had phrenic nerve paralysis during right pv isolation without permanent damage.One patient (b)(6) female with a prior history of paroxysmal atrial fibrillation, hypertension, diabetes and chads2 score of 2.During right pv isolation procedure the patient developed permanent symptomatic phrenic nerve palsy.The physician opinion regarding this event is that impedance monitoring, and strict monitoring of phrenic nerve function by means of regular pacing of the nerve, from the superior vena cava and the left atrium, before ablation, are crucial to avoid this complication, and should become mandatory during ablation especially of the right pvs.One patient (b)(6) female with a prior history of paroxysmal atrial fibrillation, hypertension, and chads2 score of 1.During right pv isolation the patient developed permanent symptomatic phrenic nerve palsy.The physician opinion regarding this event is that impedance monitoring, and strict monitoring of phrenic nerve function by means of regular pacing of the nerve, from the superior vena cava and the left atrium, before ablation, are crucial to avoid this complication, and should become mandatory during ablation especially of the right pvs.One patient (b)(6) male with a prior history of atrial fibrillation and chads2 score of 1.After the cardiac ablation procedure the patient developed hemorrhagic stroke.46 patients (2.1%) suffered vascular access complications, 13 patients (0.6%) developed cardiac tamponade, successfully drained in all the cases, 4 patients had transient ischemic attack, 5 patients (0.2%) presented pericardial effusion not requiring specific intervention, 3 patients (0.1%) had pericarditis, 3 patients (0.1%) had haemothorax requiring drainage in two cases, 1 patient had transient st segment elevation.No procedure-related death was reported.The bwi devices used are: navistar thermocool, or thermocool sf, cartotm system; however, catalog numbers are not available.Also non bwi products were used during this study: coolpath (st jude medical inc.Endocardial solutions), cooflex (st jude medical inc.Endocardial solutions), ensitenavxtm (st jude medical inc.Endocardial solutions).

• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4194807
• MDR Text Key: 5103126
• Report Number: 2029046-2014-00389
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NAVISTAR
• Device Catalogue Number: NAVISTAR
• Device Lot Number: UNKNOWN_D-1266-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR