MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_CELSIUS THERMOCOOL

Catalog Number UNK_CELSIUS THERMOCOOL

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

Patient Problems Death (1802); Sepsis (2067); Perforation of Esophagus (2399)

Event Date 03/28/2019

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.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

This complaint is from a literature source.The following complications were reported in this publication: a (b)(6) year-old male patient underwent catheter ablation of atrial fibrillation and suffered fatal esophageal¿pericardial fistula 19 days post procedure.The esophageal injury was surgically repaired and the patient was discharged with a central catheter for antibiotics administration.Eight days following his discharge (18 days post thoracotomy), the patient was brought back to the emergency department unresponsive.A magnetic resonance imaging (mri) of his brain revealed innumerable acute bilateral cerebral and cerebellar infarctions suggesting possible septic emboli.The patient was intubated, started on broad-spectrum antibiotics, vasopressors, and supportive care measures, which yielded only marginal clinical improvement.The patient was transferred to hospice care where he succumbed to multi-organ failure.Autopsy later revealed a right atrial thrombus leading us to believe the septic emboli were dislodged from an infected picc line that had been previously withdrawn 1h prior to his clinical deterioration.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.There is 1 death event and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected devices is thermocool 3.5mm.Other biosense webster devices that were also used in this study: lasso.Non-biosense webster devices that were also used in this study: none.Publication details: title: fatal esophageal¿pericardial fistula as a complication of radiofrequency catheter ablation.Objective: to describe a case of a fatal sophageal¿pericardial fistula as a complication of radiofrequency catheter ablation.Methods: a (b)(6) year-old male was evaluated in our cardiology department for recurrent paroxysmal atrial fibrillation.The rfa was performed using the carto three-dimensional (3d) mapping system, lasso catheter was used for pulmonary vein localization, and a thermocool (biosense webster) 3.5mm irrigated ablation catheter was used for segmental pulmonary vein isolation (pvi), without any additional substrate linear lesions performed.The patient initially discharged after the procedure with no acute complication.Date of event will be 37 days prior to the day of article publishing on (b)(6) 2019.

• Brand Name: UNK_CELSIUS THERMOCOOL
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8720256
• MDR Text Key: 148746445
• Report Number: 2029046-2019-03287
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CELSIUS THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR