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

Model Number D134801

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30731916l number, and no internal action related to the complaint was found during the review.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 4.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 female patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident, and a thrombosis was retrieved.Cerebral infarction occurred after the procedure.As a result of thrombus was collected, a thermal coagulation-like char was confirmed.The patient was under follow-up observation.The physician's opinions on the relationship between the event and the product is that char occurred and the causal relationship cannot be ruled out.Additional information was provided.The physician¿s opinion on the cause of this adverse event is that char occurred frequently from (b)(6) 2022 to (b)(6) 2022, and the causal relationship cannot be ruled out.They stopped the use of the product until cause and measures are provided.Intervention provided includes collection of the thrombus and the patient was under follow-up observation.The patient did require extended hospitalization because of the adverse event, but details are unknown.Relevant tests and laboratory data include thrombus collection, and a hot coagulation-like char was confirmed.There was no thrombus attached on the catheter reported.The patient has exhibited neurological symptoms since the procedure was completed as noted in the description.Follow up has been requested regarding statement, ¿the physician¿s opinion on the cause of this adverse event is that char occurred frequently from (b)(6) 2022 to (b)(6) 2022, and the causal relationship cannot be ruled out.They stopped the use of the product until cause and measures are provided.¿ should additional information become available this complaint will be reassessed accordingly.The adverse events were assessed as 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.The thrombus issue was assessed as mdr reportable.

Manufacturer Narrative

Additional information was received on 05-sep-2022 stating no issues were reported related to temperature and flow on the catheter.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® 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15044103
• MDR Text Key: 296081874
• Report Number: 2029046-2022-01644
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30731916L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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 WITH CARTO MERGE; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN)
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Female