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

Catalog Number	D132705
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Respiratory Failure (2484); Pericarditis (4448)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31452436m and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.Manufacturer's ref.# (b)(4).
Event or Problem Description
A patient underwent a repeat cardiac ablation procedure on (b)(6) 2025 with a thermocool smarttouch and the patient experienced pericarditis and low oxygen saturation which required medical intervention.On (b)(6) 2025, patient experienced low oxygen saturation (ae#1) categorized as moderate and not serious.Relationship to study device is not related and relationship to the repeat study procedure is causal.The outcome is recovered/resolved with an end date of (b)(6)2025.Intervention was oxygen.On (b)(6) 2025, patient experienced hematoma left wrist puncture site (ae#2) categorized as mild and not serious.Relationship to study device is not related and relationship to the repeat study procedure is causal.The outcome is not recovered/not resolved.Intervention was none.On (b)(6) 2025, patient experienced pericarditis (ae#3) categorized as moderate and not serious.Relationship to study device is not related and relationship to the repeat study procedure is casual.The outcome is not recovered/not resolved.Intervention was medication.

• 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: 21349347
• Report Number: 2029046-2025-00385
• Device Sequence Number: 9078475
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)271009(10)31452436M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: D132705
• Device Lot Number: 31452436M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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: 10.5FR 28MM BALLOON ABLAT CATH; CARTO 3 SYSTEM; GUIDESTAR SHEATH; LASSOSTARNAV,10P,15MM DIA LOOP; NGEN RF GENERATOR; OCTA,STD,48P,2-2-2-2-2,D-CURVE
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown