MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, WORLD WIDE CONFIGURATION; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number D138401

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

Patient Problem Fistula (1862)

Event Date 06/10/2023

Event Type  Death  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Note: per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.Note: an exact date of death was not provided.Best estimate is on (b)(6) 2023 based on an "event" date provided.As such, field b2.Date of death has been populated with this date.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: 2029046-2023-01518 for product code unk_smart touch bidirectional (thermocool® smart touch¿ bi-directional navigation catheter).(2) mfr for product code d138401 (ngen rf generator, world wide configuration).

Event Description

It was reported a patient undergoing a redo atrial tachycardia cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a ngen rf generator, world wide configuration and the patient experienced esophageal fistula and death.It was reported the patient had the procedure on (b)(6) and the procedure ended without any issues.The patient came back to the hospital with esophageal fistula on the weekend on (b)(6) (no exact date has been provided at the moment), the patient then died due to his complications.Additional information received indicates the esophageal injury was confirmed after a second cavotricuspid ishmus (ct) imagen was administered in the hospital after 1 month.An earlier ct scan did not show a fistula.The physician¿s opinion on the cause of death was thrombo embolic cerebral events and severe sepsis.Details about the death event were based on the physician's feedback given shortly after the event.The patient received a 4th redo for highly symptomatic and high burden of reoccurrence of at; this procedure it shows 4 isolated veins; patient in at (atrial tachycardia); an anterior roof line was not blocked in a first attempt; a second roof line is placed next to the first one a bit more posterior then the first line; this modifies the cycle length of the tachycardia; a new activation map suggests a different wavefront of the tachycardia and an anterior isthmus line is placed connecting the isolated right superior, anterior vein to the mitral annulus.After a couple of points ablating, the patient regained sinus rhythm.One month later, the patient comes in the hospital via the emergency department showing severe neurological malfunction and combined with fever.A ct is performed an no clear-cut diagnosis is set; a full ablation therapy is given and a new ct is performed showing the fistula.The patient deteriorates and dies.It was reported no error messages were observed on biosense webster equipment during the procedure.Modalities were used to prevent esophageal injury which included an esophageal temperature probe (biotronik).Ablation catheter was not a surround flow.Force visualization features used were graph, dashboard, vector, and visitag.No additional filter used with visitag.Color options were tax index.The generator parameters were set to power control - 42 - 45.An ngen pump was also used during this case; no malfunctions were reported.

Manufacturer Narrative

It was reported a patient undergoing a redo atrial tachycardia cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a ngen rf generator, world wide configuration and the patient experienced esophageal fistula and death.It was reported the patient had the procedure on the 12th of may and the procedure ended without any issues.The patient came back to the hospital with esophageal fistula on the weekend of the 10th of june (no exact date has been provided at the moment), the patient then died due to his complications.Additional information received indicates the esophageal injury was confirmed after a second cavotricuspid ishmus (ct) imagen was administered in the hospital after 1 month.An earlier ct scan did not show a fistula.The physician¿s opinion on the cause of death was thrombo embolic cerebral events and severe sepsis.Device investigation details: the device investigation was completed on 27-jul-2023, which included a device history record (dhr) review.The device history record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Repair follow-up was performed by the remote support team as the device was not shipped for service or repair.It was confirmed that the system was performing as intended and service was declined by the customer.As such, the reported 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).

• Brand Name: NGEN RF GENERATOR, WORLD WIDE CONFIGURATION
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17334161
• MDR Text Key: 319178316
• Report Number: 2029046-2023-01519
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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 Catalogue Number: D138401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIOTRONIK ESOPHAGEAL PROBE; CARTO 3 SYSTEM; NGEN PUMP; NGEN PUMP, EU CONFIGURATION; UNK_SMART TOUCH BIDIRECTIONAL
• Patient Outcome(s): Required Intervention; Death