MAUDE Adverse Event Report: MEDTRONIC IRELAND FLEXCATH CONTOUR¿ STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	10FCC13
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pvi procedure, the physician was having trouble gaining access to the femoral vein with the sheath 10fcc13 flexcath contour 10f.The distal end of the catheter was found to be bent, which prevented vein access.The patient was under general anesthesia and the case was completed without incident.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Product event summary: the 10fcc13 sheath of lot number 0012816909 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.All the handle, shaft and sideport were intact with no apparent issue.The functional testing was performed.No anomaly was discovered.The steering mechanism and deflection tests were completed successfully.Primary deflection at 90° and 180°, as well as secondary deflection at 90°, were achieved without any issues.The mechanism operated smoothly, with no friction, resistance, or unusual noise.The returned dilator was inserted into the returned sheath and retracted several times, without any friction.The dilator was snap-locked to the sheath and was tight.The luer and tip was intact without any issue.The catheter was inserted into the returne d catheter and retracted several times, without any friction.The relevant sub-assembly inspection and tests were performed.No anomaly was discovered.In conclusion, the sheath passed the return product inspection.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: FLEXCATH CONTOUR¿ STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23605179
• Report Number: 9612164-2025-05752
• Device Sequence Number: 21133110
• Product Code: DRA
• UDI-Device Identifier: 00763000659080
• UDI-Public: (01)00763000659080(17)270516(10)0012816909(20)01
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K232321
• 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): 01/13/2026

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: 10FCC13
• Device Catalogue Number: 10FCC13
• Device Lot Number: 0012816909
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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
• Patient Sex: Male
• Patient Weight: 78 KG