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

Model Number D134801

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 04/21/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia - left (l-idvt) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.It was reported that during a procedure there was an adverse event.They reported that during a pvc ablation while in the left ventricle, there was a steam pop.They stated that they believed that the steam pop led to a perforation that resulted in pericardial effusion.They reported that when the steam pop occurred, the physician was ablating and there was an impedance spike.The physician immediately went off of radio frequency and checked the pericardial space with the ultrasound.They stated that the physician discovered a pericardial effusion.They reported that no other patient symptoms were present at that time.The physician confirmed the effusion on ice.The physician performed a pericardiocentesis and 2 liters of the fluid was removed.They stated that as the physician waited and made sure the patient was stable, the patient's blood pressure started dropping.The physician checked a second time and confirmed that there was fluid building.The physician had to go in a second time and remove more fluid.The physician decided to contact the surgeon to be on standby.They were unsure of how much fluid was removed the second time (they guessed it was approximately 2 more liters of fluid).They reported that they also had to perform a blood transfusion.The patient was also being provided medication to stop the bleeding.After 2nd intervention, they monitored the patient for a while a second time, and the patient was eventually transported to the cv icu.They reported that the patient is currently in stable condition.Both the smarttouch sf df catheter and the soundstar catheter were in the body at the time of the adverse event.The catheters are unavailable for return and the caller could provide no product information for either.They did note that the smarttouch sf catheter was a d-curve bidirectional catheter.Additional information was received.Intervention provided was intubation and pericardiocentesis.Patient required extended hospitalization because of the adverse event as the patient remained intubated and in the cv icu until sunday, 23rd.Until yesterday (tuesday 27th) he remained in the hospital recovering.The patient had no previous procedures.Transseptal puncture was not performed.Irrigated catheter was used in the event, the flow setting was default settings.No error messages observed on biosense webster equipment during the procedure.Visitag module was used, parameters for stability used was range: 3, time: 3, fot: 25% for 3, tag size: 3.Additional filter used with the visitag was respiration.Color options used prospectively was impedance drop.The adverse event was assessed as mdr reportable.Since the event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious.The steam pop issue was assessed as non reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.The high impedance issue was assessed as non reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

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

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).During an internal review on 19-may-2023, noted a correction to the 3500a initial.Removed the h6.Medical device problem code of high readings (a090807).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16959781
• MDR Text Key: 315535599
• Report Number: 2029046-2023-01095
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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
• Treatment: SMARTABLATE GENERATOR KIT-US; UNK_CARTO 3; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG