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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a pulse field cardiac ablation procedure, after assembling the catheter and connected to the catheter interface cable (cic), the cable could not be properly connected, the catheter could not be fully inserted, and multiple channels did not display signals.It was reported that there was a large amount of glue residue at the catheter tail cable interface and assessed that the catheter needed to be replaced to proceed with ablation.The catheter was replaced with another catheter; after standard assembly and attempted cable connection, the same issues were reported, including inability to properly connect the cable, inability to fully insert the catheter, multiple channels not displaying signals, and a large amount of glue residue at the catheter tail cable interface.The catheter was replaced again and the case was successfully completed.No patient complications have been reported as a result of this event.

• 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 ; 091708096
• MDR Report Key: 25511550
• Report Number: 3002648230-2026-00667
• Device Sequence Number: 16078618
• Product Code: QZI
• UDI-Device Identifier: 00763000617554
• UDI-Public: (01)00763000617554(17)270121(10)0013231588(20)04
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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 Model Number: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0013231588
• 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: 06/10/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 01/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRODUCT ID: PSCC100 PRODUCT TYPE: CATHETER.
• Patient Sex: Unknown