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 Stenosis (2263)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It was reported that a 59-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered pulmonary vein stenosis post ablation.It was reported that following an afib case in (b)(6), the exact date is unknown, that the patient was discovered to have pulmonary vein stenosis of three of the pulmonary veins and the other pulmonary vein was discovered to be completely occluded.The patient was having difficulty exercising and difficulty breathing.They are unsure when the symptoms began but that the injury was confirmed with a ct on (b)(6) 2022.They plan on performing a medical intervention to attempt to open up the veins, but no medical intervention had been provided yet that the bwi sales consultant was aware of.The patient had one afib procedure in (b)(6) 2021 and another afib procedure in (b)(6) 2022.The patient was reported to be in stable condition.Another physician looking into the case suspected the injury may be due to the repeat atrial fibrillation procedure.The physician¿s opinion on the cause of this adverse event is that it was procedure related.They plan to stent the pulmonary veins as intervention.The patient outcome of the adverse event is ongoing.The patient did not require extended hospitalization because of the adverse event.A smartablate rf generator stockert gmbh, serial # (b)(4) was used in the event.The catheter is unavailable, and the lot number is unknown.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14953779
• MDR Text Key: 295477620
• Report Number: 2029046-2022-01554
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/08/2022
• 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: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male