MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1327-00-S

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Death (1802); Fistula (1862); Weakness (2145)

Event Date 12/21/2015

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4) are related to the same incident.

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and stockert 70 rf generator and suffered esophageal fistula, cerebrovascular accident, and death.On (b)(6) 2015, ablation was performed which consisted of pulmonary vein isolation and left atrial roof line.Smarttouch ablation catheter used with stockert 70 generator.Esophageal temperature monitoring showed no rise above 37°c.On (b)(6) 2015, patient presented to emergency room with sudden-onset left-sided weakness affecting the arm and leg.Patient admitted for signs and symptoms of stroke.Symptoms worsened over time.Patient diagnosed with multifocal cerebral embolic infarcts secondary to air emboli from esophageal atrial fistula.Patient's family decided to withdraw care and to place patient in hospice care.On (b)(6) 2015, patient expired.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5451491
• MDR Text Key: 38708277
• Report Number: 9673241-2016-00112
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2016

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: D-1327-00-S
• Device Catalogue Number: D132700
• Device Lot Number: UNKNOWN_D-1327-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR