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

Model Number	BDI35FJRT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinical trial, it was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf bi-directional catheter on (b)(6) 2022.The patient suffered a deep vein thrombosis on (b)(6) 2022 requiring prolonged hospitalization.On (b)(6) 2022 deep vein thrombosis occurred.Per the study investigator the severity of the event was mild and considered serious.The patient did suffer a serious deterioration in health.The event was not life-threatening illness or injury and there was no permanent impairment.The patient did require prolongation hospitalization from (b)(6) 2022 to (b)(6) 2022.Medical or surgical intervention was not necessary to prevent life-threatening illness or injury or permanent impairment.The patient did receive an unknown medication.The outcome is recovering/resolving.Cardioversion, re-ablation, surgery or other intervention were not required.Per the study investigator the relationship to study device was not related but the relationship to study procedure was a causal relationship.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 11-apr-2022.Per the study investigator the severity of the event was moderate and considered serious.The event is related to the index procedure.Additional information was received on 21-apr-2022.The thrombosis was related to the procedure, but not to a device deficiency.Additional information was received on 22-apr-2022.The event is serious and procedure related, in the opinion of the investigator and in accordance to the list of expected events in the protocol has been changed from does not meet criteria to expected/anticipated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation was completed on 06-may-2022.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 number 30308717l 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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 27-sep-2023.The outcome is updated to recovered/resolved from recovering/resolving.The end date value is 17-jun-2022.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® SF BI-DIRECTIONAL CATHETER
• Common Device Name: 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 ; 6465917981
• MDR Report Key: 14049436
• Report Number: 2029046-2022-00753
• Device Sequence Number: 5881393
• Product Code: LPB
• UDI-Device Identifier: 10846835002843
• UDI-Public: 10846835002843
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: BDI35FJRT
• Device Catalogue Number: BDI35FJRT
• Device Lot Number: 30308717L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 05/06/2022; 09/27/2023
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/05/2022; 05/07/2022; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male