MAUDE Adverse Event Report: Medtronic CryoCath LP PulseSelect; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number	PSCC100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Speech Disorder (4415)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: PulseSelect
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): Medtronic CryoCath LP; 9000 autoroute transcanadienne; pointe¿claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): Medtronic CryoCath LP; 9000 autoroute transcanadienne; pointe¿claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50679680
• Report Number: 3002648230-2026-01002
• Device Sequence Number: 14772176
• Product Code: QZI
• UDI-Device Identifier: 00763000617554
• UDI-Public: (01)00763000617554(17)280303(10)0013314714(20)07
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P230017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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 Model Number: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0013314714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown