MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	4FC12
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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulse ablation procedure, the sheath suddenly could not be bent.Repeated troubleshooting was performed, but the issue could not be resolved.The sheath was replaced, which resolved the issue. the case was completed with pulsed field ablation.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0012643462 was returned and analyzed.Visual inspection of the shaft area was performed.The inspection identified a shaft kink/twist at two locations approximately 1.5 inches and 2.5 inches from the tip.Functional testing of the steering mechanism and deflection revealed the shaft did not move and not bend.Dissection of the returned sheath revealed a broken pull wire in the handle area.In conclusion, the sheath failed the returned product inspection due to a kink/twist observed on the shaft and a broken pull wire observed inside the handle.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 ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• 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: 22567073
• Report Number: 3002648230-2025-00659
• Device Sequence Number: 9347703
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: (01)00763000418052(17)270203(10)0012643462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123591
• 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): 07/22/2025

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: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0012643462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: Unknown