MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP PULSESELECT; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number	PSG100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
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 prior to a pulsed field ablation procedure, an error message was received indicating that there was an embedded power-on-self-test (post) failure.The failure was verified and not resolved.Multiple troubleshooting steps were attempted, including rebooting the device several times and rebooting without the cables attached, but no resolution was found.The unit was onsite for evaluation.Technical services recommended replacement of the evaluation unit and depot repair of the broken unit.A backup device was used.Despite this, the case was aborted and the patient was under general anesthesia.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: 22292350
• Report Number: 3002648230-2025-00541
• Device Sequence Number: 15676612
• Product Code: QZI
• UDI-Device Identifier: 00763000617530
• UDI-Public: 00763000617530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (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): 06/19/2025

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 Model Number: PSG100
• Device Catalogue Number: PSG100
• 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: 06/16/2025
• Initial Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown