MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS

Model Number	C304-HIS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 implant, there were difficulties slitting the guidewire.It was noted that the wire in the deflection mechanism was caught in the slitter which resulted in the tip of the guidewire being unable to be cut.The guidewire was cut, removed, then replaced. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5 product event summary: the delivery catheter was returned and analyzed.The shaft on the hub of the delivery catheter was spiral slit.There was an issue with the catheter shaft.The shaft of the delivery catheter was spiral slit.The peeling/slitting/splitting was not slit on the center of hub of the delivery catheter.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned without the dilator and slitter.Slitting did not start on the centerline on the hub of the delivery catheter.Slitting had terminated at 19.8 cm on the shaft of the delivery catheter and slitting was then restarted.Spiral slitting of the shaft of the delivery catheter had exposed the deflection wire at 23.4 cm.Spiral slitting on the shaft of the delivery catheter had aligned with the deflection wire and band to stop slitting at 44.2 cm and then slitting had resumed.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 implant, there were difficulties slitting the delivery catheter.It was noted that the wire in the deflection mechanism of the delivery catheter was caught in the slitter which resulted in the tip of the delivery catheter being unable to be cut.The delivery catheter was cut, removed, then replaced.No patient complications have been reported as a result of this event.

• Brand Name: SELECTSITE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23477594
• Report Number: 9612164-2025-05438
• Device Sequence Number: 16009673
• Product Code: DQY
• UDI-Device Identifier: 00763000147013
• UDI-Public: (01)00763000147013(17)261219(10)0012596527
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K183493
• 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,Followup
• Report Date (Section B): 11/21/2025

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: C304-HIS
• Device Catalogue Number: C304-HIS
• Device Lot Number: 0012596527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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: 66 YR
• Patient Sex: Female