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

Model Number 2ACH20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Bacterial Infection (1735); Stroke/CVA (1770); Erythema (1840); Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Dizziness (2194); Cardiac Tamponade (2226); Syncope/Fainting (4411)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/64 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: efficacy and safety of proglide use and early discharge after atrial fibrillation ablation compared to standard approach.Profa trial.Pacing and clinical electrophysiology.2023; 46:598¿606.Doi: 10.1111/pace.14753 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 Description

Literature was reviewed regarding cryoballoon ablation.Patients were divided into two groups, those with a strategy of vascular suture mediated closure system utilization and early discharge or traditional closure and overnight hospitalization.The authors described patients who experienced complications in both groups.There were six patients that had an emergency visit or were admitted in the first 30 days after procedure.One patient had a medically treated stroke with no permanent injury after discharge, there was a patient with erythema related to direct current cardioversion during atrial fibrillation ablation procedure associated with nonspecific dizziness.Another patient had thoracic pain, bleeding related to femoral access, hypotension, and troponin rise.A coronary angiography was performed with no coronary artery stenosis and a type ii myocardial infarction was diagnosed.One patient experienced access site pain and an arteriovenous fistula was diagnosed and treated with a stent.There was one with symptomatic atrial fibrillation recurrence and another patient had and emergency visit because of pulmonary infection.There were other patients that experienced syncope, bleeding in the access site, arrhythmic problems (nodal rhythm after electrical cardioversion, sinus pauses after electrical cardioversion and monomorphic ventricular tachycardia after electrical cardioversion), hypotension, suspected pericardial tamponade that was not confirmed by echocardiography, and temporary phrenic paralysis.The status of the catheters and sheaths is unknown.No additional adverse patient effects were reported.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER
• Type of Device: 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: 19053246
• MDR Text Key: 339551189
• Report Number: 2182208-2024-01493
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 84 KG