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

Model Number	12FCC13
Medical Device Problem Codes	Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a medical procedure involving a balloon catheter and a sheath, several issues were identified.The catheter was not recognized by the system, and the deflection mechanism of the sheath broke, leading to a loss of steerability.The doctor heard a snapping sound during deflection, after which the sheath could no longer deflect.To address these issues, the balloon catheter and the sheath were both replaced.The procedure was successfully completed using cryoablation.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: 12fcc13 sheath with lot number 0012253571 was returned and analyzed.Visual inspection of the handle area was performed.The inspection identified a kink at the side port tube.The shaft and tip of the sheath were intact with no apparent issue.The steering mechanism and deflection test were performed.The shaft does not move and not bend.During dissection and inspection, the pull wire was observed to be broken inside handle.In conclusion, the sheath failed the returned product inspection due to a broken pull wire and side port tubing kink.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: 21378814
• Report Number: 9612164-2025-00781
• Device Sequence Number: 3849183
• Product Code: DRA
• UDI-Device Identifier: 00763000234928
• UDI-Public: 00763000234928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/13/2025

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 Expiration Date: 05/03/2026
• Device Model Number: 12FCC13
• Device Catalogue Number: 12FCC13
• Device Lot Number: 0012253571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AFAPRO28 BALLOON CATHETER
• Patient Sex: Prefer Not To Disclose