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

Model Number	PSCC100
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac ablation procedure, during guidewire advancement toward the left superior pulmonary vein, fluo roscopy showed a foreign object emerging near the sheath tip.The physician withdrew the system, and the foreign object retracted into the sheath; upon a subsequent guidewire advancement attempt, the foreign object reappeared.A foreign object was alleged to have been introduced inside the sheath, and with uncertainty whether it originated from the catheter or from material shaved within another sheath or introducer.A foreign object was also reported inside the catheter and was drawn out by the guidewire while it was being positioned.No resistance was encountered during advancement through the sheath.Intracardiac echocardiography reportedly visualized the foreign object during the procedure.The case was aborted the patient was under general anesthesia. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: 10fcc13 product type: sheath.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 50692859
• Report Number: 3002648230-2026-01004
• Device Sequence Number: 21236040
• Product Code: QZI
• UDI-Device Identifier: 00763000617554
• UDI-Public: (01)00763000617554(17)260813(10)0012965531(20)04
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Model Number: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0012965531
• 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: 09/09/2026
• Date Device Manufactured: 08/13/2025
• 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: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female