MAUDE Adverse Event Report: COVIDIEN LLC PULSESELECT; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number	PSCC100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiac ablation procedure, there were issues related to steering and deflection.The slider on the handle was described as rigid and hard to move.The catheter was replaced.The case was completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the pscc100 catheter with lot number 0012783304 was returned and analyzed.No anomalies were identified during external visual inspection of the shaft and handle.During inspection of the array, an inverted array was observed and the proximal end of the nitinol array wire was observed to be dislodged from dual lumen.The catheter chip was reprogrammed for functional testing with the generator, which could not be performed due to the condition of the returned catheter.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 did not reveal any anomalies.In conclusion, the catheter failed the returned product inspection due to nitinol array wire dislodgement from the dual lumen and an inverted 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): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer (Section G): COVIDIEN LLC; 6135 gunbarrel ave; boulder,co
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23855412
• Report Number: 2936999-2025-00596
• Device Sequence Number: 5030664
• Product Code: QZI
• UDI-Device Identifier: 10884521190955
• UDI-Public: (01)10884521190955(17)440526(10)0012783304
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/19/2025

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: 0012783304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 64 YR
• Patient Sex: Male