MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134722IL

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

Patient Problem Stroke/CVA (1770)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

E 1.Initial reporter facility name (cont.): (b)(6) medical university.E1.Initial reporter phone: (b)(6).According to the picture provided by the customer, char was observed.No evidence related to the adverse event reported was observed in the picture.A manufacturing record evaluation was performed for the finished device number 30907142l, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate to find the root cause of the complaint.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a cerebrovascular accident and required prolonged hospitalization.It was reported that during the procedure, the physician removed the catheter from the patient¿s body after ablating normally.Char was found on the catheter tip.The patient experienced hemiplegia in the left hand and foot, and consciousness blurred.A computerized tomography (ct) and cerebral angiography revealed a cerebral infarction in the patient.The physician used a retrieval stent to remove the char to complete the surgery.The patient has been transferred to the intensive care unit (icu) and was stable at the time of the call.The procedure was prolonged for about four hours.The char was assessed as not mdr reportable.Char is a physical phenomenon of radiofrequency (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.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.

Manufacturer Narrative

Additional information was received on 24-may-2023.It was reported that the adverse event was discovered post use of biosense webster products.The physician suspected that the craftsmanship of the tip of the product which may lead to the formation of eschar during the ablation process.The procedure was same as usual, unchanged, using 50w and default setting of 8ml/min water flow.Cerebral infarction in patients due to the detachment of eschar from the catheter tip to the cerebral vessels.¿emergency thrombectomy within the mind was performed¿.As such, the h 6.Health effect - impact code of ¿surgical intervention (f19)¿ was added.Outcome of the adverse event was improved.The eschar was successfully removed with a good prognosis and was still being observed in the ward.The patient was transferred to the icu for further observation and treatment after successful thrombectomy due to cerebral infarction.A smartablate generator kit (cn) was used (product code m4900407 / g4c-5907).As such, the concomitant product section was updated.There was no problem with the generator, so no service was needed.Device evaluation details: the biosense webster inc.(bwi) product analysis lab received the device for evaluation on 06-jun-2023.The device evaluation was completed on 13-jun-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a cerebrovascular accident and required surgical intervention and prolonged hospitalization.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed char residues in the dome.The device features were reviewed, and during the product investigation, no temperature, impedance or irrigation issues were observed; therefore, no evidence related to the adverse event reported was found.A manufacturing record evaluation was performed for the finished device 30907142l number, and no internal actions related to the reported complaint condition were identified.The char issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 16977714
• MDR Text Key: 315703585
• Report Number: 2029046-2023-01122
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Catalogue Number: D134722IL
• Device Lot Number: 30907142L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female