MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number	2ACH15
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiac ablation procedure, there were issues with inserting the mapping catheter into the balloon catheter.Post ablation, the balloon catheter was removed from the patient in order to post map and check pulmonary vein isolation.Upon attempting to reinsert the balloon catheter for further ablations, the catheter became difficult to pass through the flexcath sheath.A kink was observed in the balloon catheter near the distal end.The balloon catheter was re-prepped but then the mapping catheter would not advance to the end of the balloon.A kink was also noted in the mapping catheter when removed.Both the balloon and mapping catheters were replaced.The case was completed with cryo.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 2ach15 mapping catheter with lot number 9085337 was returned and analyzed.Visual inspection showed the loop was pinched near the tip, the pebax tubing area was intact with no apparent issues or damage, electrodes one and five were bent/crushed, the shaft was kinked approximately 13.5 inches from the lemo connector, the introducer was intact with no apparent issues or damage, and the lemo connector was intact with no apparent issues or damage.In conclusion, the reported mapping catheter kink was confirmed during analysis.The mapping catheter failed returned product inspection due to a kink/twist observed on the catheter shaft, a deformed electrode observed on the loop of the pebax tubing, and a pinch observed at the tip/loop of the pebax tubing.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: ACHIEVE ADVANCE MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21704053
• Report Number: 2182208-2025-01536
• Device Sequence Number: 21350120
• Product Code: DRF
• UDI-Device Identifier: 00643169590960
• UDI-Public: 00643169590960
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162892
• 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): 04/29/2025

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: 06/11/2026
• Device Model Number: 2ACH15
• Device Catalogue Number: 2ACH15
• Device Lot Number: 9085337
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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 Age: 52 YR
• Patient Sex: Male