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

Model Number D134805

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

Patient Problem Stroke/CVA (1770)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

The product investigation was completed.Visual analysis revealed no damage or anomalies on the device, and no char residues were observed however, according to the decontamination site, char was observed on the tip area.The lost of the char residues could be related to the decontamination process.Per the event, several tests were performed.The magnetic, electrical, temperature, and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device number lot 30953923l and no internal action related to the complaint was found during the review.The issue reported by the customer regarding char was confirmed.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The instructions for use contain the following guideline: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.No device malfunction was found that could be contributed to the adverse event.The root cause of the adverse event remains unknown.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 an atrial fibrillation (afib) with a thermocool® smart touch® s f bi-directional navigation catheter.The patient suffered cerebrovascular accident.It was reported that when the catheter was pulled out of the body they noticed char on the catheter.They stated that this was noticed at the end of the case and there was no error displayed on carto 3 system to let them know anything was going on.They are requesting the catheter be replaced and sent in for evaluation.They are sending the cable in for an evaluation as well but do not want it replaced.It was also reported that after an afib case, a stroke was noticed.They reported the patient could not use his left side.The stroke was confirmed by mri.The medical intervention provided was stroke protocol.The patient was reported to be in stable condition.The following bwi devices were in use: carto 3 (3035519) additionally, the event was noted post use of product.The char was on the tip of the electrode.No error messages nor did the physician/user see any product problem on the system.Generator parameters are unknown by reporter as the generator was sent off for evaluation and reporter does not have the data.Correct flow rates were used.Patient was anticoagulated.Chat is not mdr-reportable.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 and mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® S F 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: 16616958
• MDR Text Key: 312011750
• Report Number: 2029046-2023-00640
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30953923L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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 GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male