MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133602
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericarditis (4448)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Note: for field d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.Note: field d4.Catalog should be unk_smart touch unidirectional sf.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a smart touch unidirectional sf and the patient experienced pericarditis that required hospitalization.The caller says she has not had pericarditis in a long time using smart touch unidirectional sf and has questioned whether the ngen settings may have caused this; however, there were no specific device malfunctions noted with the ngen.The workflow has always been, posterior: 10second cut off ¿ 50w.Anterior: no time cut off ¿ ablation index target of 400.Pre-flow was set at: 1- 2 sec.Post flow: 0 sec.Ablation was not excessive, and force was reasonable with an average of 5-15g.Additional information was received on 27-mar-2025 which indicated that no intervention was required, however, the patient with pericarditis was re-admitted the next day with chest pain but were discharged within 24 hours.The patient fully recovered.Relevant labs and tests included: echoes showed no effusion, troponins were elevated, ecg showed signs of pericarditis.The physician's opinion on the cause of the adverse event is that it was patient condition related.It was reported that activated clotting time (act) was within range throughout the procedure, physician adheres to 350 for all her pulmonary vein isolations (pvi).It was also noted that the pericarditis was noted prior to ablation, however, it was also reported that the event occurred post procedurally.No error messages observed on biosense webster equipment during the procedure.This event was originally considered non-reportable as there was no indication that the pericarditis required medical or surgical intervention or that the event was life threatening.There was no indication that the event resulted in permanent impairment of a body function or permanent damage to a body structure and there was no report of prolonged hospitalization.It was on 27-mar-2025 that bwi became aware of additional information which changed the reportability to mdr reportable for the prolonged hospitalization.
Additional Manufacturer Narrative
On 8-apr-2025, additional information was received indicating the physician uses uni directional f curve catheter.These are the settings she was used to from the uk.Based on this new information, the following information has been updated: field d4.Brand name was updated from ¿smart touch unidirectional sf¿ to ¿thermocool smarttouch¿ field d4.Catalog was updated from ¿see h11.¿ to ¿d133602¿.Field d4.Primary udi number was updated from ¿ (b)(4).Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 SMARTTOUCH
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21733708
• Report Number: 2029046-2025-00985
• Device Sequence Number: 8735487
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Catalogue Number: D133602
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BRK-1 NEEDLE; NGEN PUMP, EU CONFIGURATION; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White