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

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent an atrial flutter ablation and the patient experienced neurologic impairment that required medical intervention and prolonged hospitalization.It was reported that the patient had a "vagal response".The symptoms that the patient was displaying were a drop in blood pressure, the patient urinating, and the patient was unable to answer questions.The patient was then sent to the intensive care unit (icu) where they ordered an echocardiogram (echo).No further tests were performed in the lab.The physician believes the patient just had a vagal response that occurred while the scrub tech was holding pressure on the groin after sheaths were removed.Fluids and dopamine were provided to help with blood pressure and the patient was transported to icu.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter ablation and the patient experienced neurologic impairment that required medical intervention and prolonged hospitalization.It was reported that the patient had a "vagal response".The symptoms that the patient was displaying were a drop in blood pressure, the patient urinating, and the patient was unable to answer questions.The patient was then sent to the intensive care unit (icu) where they ordered an echocardiogram (echo).No further tests were performed in the lab.The physician believes the patient just had a vagal response that occurred while the scrub tech was holding pressure on the groin after sheaths were removed.Fluids and dopamine were provided to help with blood pressure and the patient was transported to icu.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31151876l, and no internal action related to the complaint was found during the review.Additionally, the manufactured and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.No malfunction was observed during the product analysis.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® 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: 18483996
• MDR Text Key: 332555810
• Report Number: 2029046-2024-00123
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31151876L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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; THMCL SMTCH SF BID, TC, F-J; UNKNOWN NON BWI SHEATHS; UNK_ISMUS
• Patient Outcome(s): Hospitalization
• Patient Sex: Male