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 11/16/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.It was reported by the bwi representative that they overheard the physician talking with another doctor about the procedure that took place earlier in the week.They stated that the patient had a hemorrhagic stroke that night following the procedure and they were unable to move their right arm and they were experiencing some pain.The patient was in the hospital when the incident took place.The patient's status is unknown, but the physician expects a full recovery for the patient.They stated that during the procedure there was nothing out of the ordinary that occurred.The patient was stable during the entire procedure with no known complications.The physician did use heparinized saline and half of the dose of heparin in the heparinized saline.While ablating in the coronary sinus they used full heparinized saline and when ablating in the left ventricle they used half the recommended dose of heparin for the heparinized saline.The physician was aware this was off-label use.They used an average of 40 watts during the ablation.It is believed the patient required extended hospitalization, but there are no further details on that.Patient information is not available.There is no further information about if any additional intervention was performed.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 ref.# (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: 15998584
• MDR Text Key: 305681772
• Report Number: 2029046-2022-03153
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BMW WIRE; REPROCESS SDSTR ECO 8F-90 SMS; SMARTABLATE GENERATOR KIT-US; STERILE MED 8 FRENCH ICE CATHETER; UNKNOWN DECANAV F CURVE CATHETER; UNKNOWN EP STAR CATHETER; UNKNOWN PUMP
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Female