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	Thermal Decomposition of Device (1071); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiac ablation procedure using the catheter pscc100 pulseselect, an alleged product issue occurred involving a cable connection problem.Error 4002 was experienced during the connection of the first catheter, and disconnecting and reconnecting the cic cable cleared the error message.However, once the catheter was placed in the patient's heart, signals from the catheter could not be observed properly as they were saturated.Changing the cic cable did not resolve the signal issue, so the catheter was replaced to resolve the issue.The second catheter was successful, and at the end of the case, both catheters were collected for investigation.The patient was under general anesthesia, the procedure was completed, and no medical or surgical intervention was needed to prevent permanent impairment.The event did not lead to or extend patient hospitalization, and no injury or complications were reported.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the pscc100 catheter with lot number 0012979011 was returned and analyzed.No anomalies were identified during external visual inspection of the array and shaft segments.During external visual inspection of the handle segment, a kink was observed on the shaft at handle nose.The pcba chip was reprogrammed for functional testing.During functional testing, the generator terminated the therapy delivery due to system error 2000 (indicating that there was an electrical current error).Deflection testing (rotating steering knob clockwise and counter-clockwise) was performed, the distal catheter tip responded with approximately 170 degrees (° 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 and other anomalies were observed along the extended portion.Electrical continuity test did not reveal any anomalies.Inspection (microscope) and testing were performed to verify the integrity of the catheter sub-components.During inspection of the shaft segment, an electrode wire was observed to be charred and kinked.In conclusion, the reported issues (cable connection issue, no signal/noise/interference (egm), and error|invalid catheter) were reproduceable.The catheter failed return inspection due to the charred and kinked electrode wire in the shaft.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 ; 091708096
• MDR Report Key: 25333142
• Report Number: 3002648230-2026-00590
• Device Sequence Number: 13180670
• Product Code: QZI
• UDI-Device Identifier: 00763000617554
• UDI-Public: (01)00763000617554(17)260821(10)0012979011(20)04
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/29/2026

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: 08/21/2026
• Device Model Number: PSCC100
• Device Catalogue Number: PSCC100
• Device Lot Number: 0012979011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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: PSCC100 CATHETER
• Patient Sex: Unknown