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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Perforation of Esophagus (2399)

Event Date 06/24/2022

Event Type  Injury  

Event Description

It was reported that a 72-year-old female patient (48 kgs) underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered and esophageal perforation requiring surgical intervention and prolonged hospitalization after the ablation procedure, patient discharged from the hospital, then the patient visited the hospital due to chest discomfort finding an esophageal perforation.After contrast imaging was performed, an esophageal perforation found.After the there was no left atrial injury (la) injury.At the time of the call, the patient was being treated at another hospital.The patient was implanted the artificial esophagus at another hospital.The patient was hospitalized at another hospital.From the carto 3 system data, there was a single point of increase in ai 500.Additional information received indicated the transseptal puncture was most probably performed.No steam pop was reported.No error messages were reported.Force visualization features were used were real time graph, dashboard, vector and visitag with tag index and no additional filter used with the visitag.The patient was reported to be doing well with condition improved.The settings were sa: pre1, post3.Normal operation was performed.There was no additional filter.Preference: 3mm, 3s, 25%, 5g, low400, high450, 40w.Tag size is 2mm.The smartablate generator was used appropriately with the correct catheter settings selected.In order to ensure that the settings are correct, a tape was attached to prevent the problems from occurring.The pump switching from ¿low¿ to ¿high¿ flow during ablation.The physician commented that a place that a single point of increase in ai 500 was on the back wall slightly above the roof.No relevant medical history.Relevant tests includes cag: contrast-enhanced examination.The physician¿s opinion on the cause of this adverse event is that it was possibly procedure related.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a 72-year-old female patient (48 kgs) underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered and esophageal perforation requiring surgical intervention and prolonged hospitalization.After the ablation procedure, patient discharged from the hospital, then the patient visited the hospital due to chest discomfort finding an esophageal perforation.After contrast imaging was performed, an esophageal perforation found.After the there was no left atrial injury (la) injury.At the time of the call, the patient was being treated at another hospital.The patient was implanted the artificial esophagus at another hospital.The patient was hospitalized at another hospital.Device investigation details: the device investigation was completed on 17-aug-2022 which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30758530l found no internal actions related to the complaint during the review.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: on 17-aug-2022 it was noticed the initial reporter¿s details were inadvertently omitted from the 3500a initial medwatch report.As such, the appropriate fields in section e have now been populated.

• 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: 15238195
• MDR Text Key: 298023629
• Report Number: 2029046-2022-01895
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30758530L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GEN. KIT (JAPAN); UNKNOWN PUMP
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR