MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Transient Ischemic Attack (2109)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an two unknown smart touch bidirectional sf.The patient suffered a transient ischemic attack.It was requested that after the issues experienced prior with the smartablate generator and the smartablate pump, the products be sent in for a diagnostic test.There was a post-procedure patient adverse event.The customer wants the unit analyzed so in this case, there was issues with rapid temperature rise from say 31 degrees pre ablation, (cath inside body and sheath to coming on and rapidly increasing with adequate flow per ifu (instructions for use) recommendations and having the catheter warn at 37degree c to quickly reaching 40 degree temp triggering appropriate termination of rf (radiofrequency) therapy.This happened with two different catheters.The catheters were removed and inspected, the ports and flow pattern appeared to not be obstructed.The physician stated that there was char on the tip.He wiped the catheter.The medical team replaced the catheter.The second stsf also had the same issues.There as no obstruction of flow, pump appeared to operate at the recommended flow rate of 15ml/min for therapy >35 watts.They were ablating at 50w.The temp continued to ramp up during our rf application.The catheter was again checked for all the usual things: obstruction of the tubing, stopcock in good alignment.There was the recommendation from me to exchange the tubing but the rate of flow when showing patency on distal catheter tip, seemed acceptable and what was standard for the catheter per the physician.The patient was therapeutic with act >350 for the procedure.Adjusting the pre and post time from what the physician wanted from a 0time pre flow and a 0flow post rf time was introduced.The physician was amicable to having a 1sec pre and 1sec post flow set for his remaining lesions.This seemed to correct any high temperature warnings.The case completed.The second catheter was destroyed by the lab staff.The service for the generator was completed earlier this year.The medical team then reported there was a complication with that patient and that the physician thinks that it might have been a catheter issue.Physician stated he saw char on the catheter tip.Physician removed clot with dry 4x4 gauze sponge.Physician felt that the catheter was able to be reinserted after we had.The catheter that was sent back was the catheter that had char."unit was identified to have been involved in a patient injury." within 24 hours, the patient was noted to have a tia (transient ischemic attack).Apparently, there was a ¿embolism shower¿ that occurred noted on a ct.(3rd hand information).The char/coagulum/thrombus/clot was located at the tip electrode.There were issues related to temperature and flow on the catheter.Generator parameters were (b)(6) 2015.Alarm at 35c cut off at 37c we were operating at power control mode.They cant remember specifically what the parameters of the generator were.The error log was provided.Act was therapeutic >300sec act.No imaging was obtained.3rd hand information was that the patient has not had long term altered mental status or any other neurological or physical complications.Since the event is 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 is to be considered serious.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 17440683
• MDR Text Key: 320204681
• Report Number: 2029046-2023-01674
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• 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; SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention; Life Threatening