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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31020292l number, and no internal action related to the complaint was found during the review.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 svt / avnrt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cerebrovascular accident.It was reported that the patient had a stroke following an svt/avnrt (atrioventricular nodal reentrant tachycardia) procedure.They reported that the patient complained that she "felt funny" within 20-30 minutes after catheters were pulled and the patient was off the table.They reported that after probing from the nurse and anesthesia, it was noticed that the patient was unable to move the right side of the body.The patient was unable to squeeze the right hand and move the right foot.It was reported that either an mri (magnetic resonance imaging) or a ct (computed tomography) was performed but the caller was unsure if a stroke was confirmed.No medical intervention had been provided.The patient was reported to be in stable condition.Service was declined.Additional information- the adverse event occurred on (b)(6) 2023.It was discovered post use of biosense products, however patient reported ¿feeling funny¿ prior to sedation or use of biosense products.Physician opinion is that it was not procedure related and an unfortunate coincidence.Likely prior condition.Patient was taken for ct scan, which came back negative.Patient was given tpa for potential tia and all symptoms resolved back to baseline.Outcome of the adverse event was fully recovered.No extended hospital stay required.Relevant tests/laboratory data- ct scan performed, unsure of other tests completed.No evidence of char.No evidence of thrombus or clot.Correct catheter settings were selected on the generator.Pump working under correct parameters.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: 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: 17032430
• MDR Text Key: 316282089
• Report Number: 2029046-2023-01185
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31020292L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2023
• 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: UNSPECIFIED GENERATOR.; UNSPECIFIED PUMP.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female