MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fistula (1862); No Code Available (3191)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded; therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Concomitant products: biosense webster inc.Product: lasso catheter, lot #: unknown, serial #: unknown.Biosense webster inc.Product: carto® 3, u.S.Catalog#: unknown, serial number: unknown.Manufacturer reference #: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf uni-directional catheter and stockert and developed a cerebrovascular accident and esophageal fistula (requiring surgical intervention).Post-procedure, the patient was admitted into emergency room (er) with symptoms from the ablation procedure.The patient had transient ischemic attacks (tias), chest pain and dysphagia every time he ate as well as rash on his chest.It was also reported that the patient suffered a cerebrovascular accident.Esophageal fistula was confirmed by ct scan.The patient was transferred to the operating room (or) to have surgery.A stent in the esophagus and a patch over the left atrium where the fistula occurred were required.The patient was then transferred to the intensive care unit (icu) and was reported to be in critical condition.Extended hospitalization was required post-surgery to monitor patient¿s condition.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, burning the tissue of the posterior wall of the left atrium caused the injury.There were no error messages observed on any biosense webster, inc., equipment during the procedure.The overall time for ablation at the site of the injury was between 5-10 seconds.The last ablation cycle time at the site of the injury is unknown.The generator was in power control mode at 40 watts with a temperature cut-off at 43 degrees celsius.An esophageal temperature probe in the esophagus was used to prevent esophageal injury.During the case, the thermocool® sf uni-directional catheter was intermittently in close proximity to the lasso catheter as well as the duodeca catheter throughout the case.

• Brand Name: THERMOCOOL® SF UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7947518
• Report Number: 2029046-2018-02138
• Device Sequence Number: 1665227
• Product Code: LPB
• UDI-Device Identifier: 10846835009347
• UDI-Public: 10846835009347
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: D131604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR