MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139501
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31561409l 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no internal action is required at this time.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 reference number: (b)(4).
Event or Problem Description
The report indicated during paroxysmal supraventricular tachycardia ablation with qdot micro¿ catheter, the patient experienced thrombotic cerebral infarction.The patient experienced a thrombotic cerebral infarction.The patient was not taking anticoagulants.No prolongation of hospital stay occurred.Causal relationship with product was unknown.During the ablation of the slow pathway with navistar catheter, the temperature ramp became alarmingly gradual.After replacing it with the qdot micro catheter, the incident did not recur, and the procedure was completed.Information received indicated that the subsequent condition of the patient remains unknown.The patient was not originally taking anticoagulants and had only inserted the catheter into the right atrium during the procedure.The physician¿s opinion on the cause of this adverse event was that the patient did not take anticoagulants.No further information is available.Delivered energy was rf (radiofrequency).Information received indicating that the temperature issue was found during ablation with navistar.No celsius catheter.
Additional Manufacturer Narrative
On 10-jul-2025, bwi received additional information indicating that the physician¿s opinion on the cause of this adverse event was that the patient did not take anticoagulants.The issue was caused by the non-administration of antithrombotic drugs after the procedure.One catheter exchange occurred during the procedure.No transseptal puncture was performed.The number of performed rf (radiofrequency) ablations were 5 ablations outside the pulmonary veins.No ablations performed in the pulmonary veins.Ngen generator/pump was used for the procedure.Due to the lack of anticoagulants, bwi has determined that this event is not fda-reportable against any of their devices.As a result, no further reports will be sent for this event.Manufacturer reference number: (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22355993
• Report Number: 2029046-2025-02127
• Device Sequence Number: 8621993
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)250117(17)280116(10)31561409L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: D139501
• Device Lot Number: 31561409L
• 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: 06/07/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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: 8.5F SHEATH, VIZ SMCURVE,SHORT; DEF 7F NS,4P,D,1-7-4MM,HYP,115; NGEN GENERATOR; NGEN PUMP; OCTA,STD,48P,2-2-2-2-2,D-CURVE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic