MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 10/30/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 79-year-old female patient (34 kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered an esophageal injury and vomited blood.Ablation was conducted for paroxysmal afib (paf) and the procedure was completed normally.A perforation did not occur during the procedure.On the following day, the patient vomited blood in the ward and was urgently transported to the nearby hospital.As a result of the examination at the nearby hospital, left atrio-esophageal fistula did not occur, and there was a disorder with inflammation in the esophagus.The physician's opinions on the relationship between the event and the product is that it was caused by slow temperature feedback of esophageal temperature monitoring catheter that was used during the procedure.It was not related to bwi product.The esophageal temperature monitoring catheter was another company¿s device (non-bwi).The cause of the inflammation in the esophagus was thought to be due to the catheter for the esophagus temperature.A ct scan showed esophageal disorder, which was mild.The generator used in the case was a smartablate.There were no error messages observed on biosense webster equipment during the procedure.Force visualization features used were real time graph, dashboard, vector and visitag with tag index and fot.There were no product malfunctions observed before/during the procedure.

Manufacturer Narrative

Additional information was received on 08-aug-2022.It was reported that the patient was transferred to another hospital; therefore, extended hospitalization was required.It is unknown if intervention was provided at the other hospital.Based on this information, the h 6.Health effect - impact code was updated.A ct scan after transfer showed esophageal disorder, which was mild.The esophageal temperature monitoring catheter (non-bwi) was used during the procedure.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.The carto® 3 system did not indicate to re-zero the catheter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15090631
• MDR Text Key: 296468299
• Report Number: 2029046-2022-01692
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/19/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 34 KG