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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an atrial tachycardia (at -left) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a punctured aorta requiring surgical intervention and prolonged hospitalization.Transseptal puncture was performed with an abbott brk tansseptal needle.Afterwards the sheath (unspecified sheath) was pulled through and then the thermocool® smart touch® sf bi-directional navigation catheter was put into the sheath.When measuring the left atrium (la) pressure, we realized that it was very high (around 100mmhg) and by that we knew that it was not la pressure, but aorta pressure.The physician decided to leave the sheath and thermocool® smart touch® sf bi-directional navigation catheter inside the aorta to prevent bleeding.Patient had to go through open heart surgery.The thermocool® smart touch® sf bi-directional navigation catheter was not involved in the complication per se and did not cause any injury itself.The surgery was delayed due to the reported event and the procedure was not able to be completed.Emergency physician made a drainage and the patient had to undergo open heart surgery.Surgery went well and patient is stable and in a good condition.Additional information received indicated the thermocool® smart touch® sf bi-directional navigation catheter was inside the body in the sheath; no mapping or ablation was performed.No evidence of steam pop because no ablation performed.The event occurred during transseptal phase of the procedure.No other bwi products were used.The physician¿s opinion on the cause of this adverse event is that it was the procedure and patient anatomy, not because of bwi products.Patient outcome from the adverse event was reported as improved.The patient required extended hospitalization because of the adverse event as the patient had to undergo open heart surgery.A smartablate generator was used during the case.Force visualization feature used was graph.Visitag module was not used.Irrigated catheter was used in the event and the flow setting at 2ml/min, however, no ablation was performed.The correct catheter settings were selected on the generator and the pump was set to switch from low to high flow during ablation, but did not ablate.No error messages were observed on biosense webster equipment during the procedure.

Manufacturer Narrative

Manufacturer's ref # (b)(4) on (b)(6) 2021, this event was re-reviewed and determined the event should not have been reported against the thermocool® smart touch® sf bi-directional navigation catheter.The thermocool® smart touch® sf bi-directional navigation catheter should be considered concomitant in this event since the adverse event was reported to have occurred during transseptal puncture and no ablation was performed with the thermocool® smart touch® sf bi-directional navigation catheter.This event is no longer considered to be mdr reportable against thermocool® smart touch® sf bi-directional navigation catheter.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12631582
• MDR Text Key: 276376511
• Report Number: 2029046-2021-01751
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30532831L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male