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

Model Number	2ACH20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Flutter (1730); Hyponatremia (4494); High White Blood Cell Count (4594); Hypocalcemia (4823); Hypokalemia (4825)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
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 approximately two weeks post-operatively to a cryo ablation procedure, the patient labs showed hyponatremia, hypokalemia, hypocalcemia, and a slightly elevated white blood cell (wbc) count.An electrolyte supplement was administered intravenously to the patient to treat the hypokalemia.Despite the patient being in sinus rhythm, the patient was cardioverted the following day.The patient was also hospitalized overnight. the patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was later reported that thirteen days post-operatively, the patient experienced atrial flutter.The atrial flutter was observed via an electrocardiogram (ecg).The patient was treated with an electrical cardioversion and hospitalized overnight.
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.

• 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: 19200660
• Report Number: 2182208-2024-01842
• Device Sequence Number: 8034598
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 8326175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/21/2024
• Date Device Manufactured: 06/20/2023
• 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: 4FC12 SHEATH, AFAPRO28 BALLOON CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 101 KG