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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that once the catheter entered the patients body, noisy electrograms were observed.The cable was reconnected and catheter interface cable was replaced without resolution.The catheter was replaced which resolved the issue. the case was completed. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the pscc100 pulseselect¿ pulsed field ablation loop catheter with lot: 0012979009 was returned and analyzed.No anomalies were identified during visual inspection of the array, shaft, and handle.The catheter passed performance functional testing with a generator; therapy deliveries were completed with no system errors generated.No performance issues were identified.Deflection testing (rotating the steering knob clockwise and counter-clockwise) was performed and the distal catheter tip responded with approximately 170° rotation in both directions.No anomalies were observed.The slide control function operated as expected without any issues.Upon full advancement of the slide control to extend the guidewire lumen, no kinks or other anomalies were observed along the extended portion.Electrical continuity testing revealed an open loop on electrode wire e9.Inspection (microscope/x-ray imaging) and testing was performed to verify the integrity of the catheter sub-components.During the inspection of the spiral array, electrode wire e9 was observed to be detached from the electrode.In conclusion, the catheter did not pass the returned product inspection due to an electrode wire to electrode detachment in the spiral array.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: 50667804
• Report Number: 3002648230-2026-00997
• Device Sequence Number: 16011275
• Product Code: QZI
• UDI-Device Identifier: 00763000617554
• UDI-Public: (01)00763000617554(17)260820(10)0012979009(20)04
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2026
• Device Model Number: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0012979009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 278 LB