MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV 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 Problem Pericardial Effusion (3271)

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that after completing the cryo ablation portion of a procedure, it was intended to switch to radiofrequency (rf) for additional ablation lines; however, a significant pericardial effusion was observed on intracardiac echocardiography (ice).A peric ardiocentesis was subsequently performed. the case was completed with cryo.Incoming information was later received indicating the patient had a thoracotomy done one month prior.A transesophageal echocardiogram (tee) was performed prior to the procedure and the e ffusion was not noted until the cryo portion of the procedure was complete.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: afapro28 product type: balloon catheter; product id: 4fc12 product type: sheath; product id: 900304 product type: dilator/needle 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.

Manufacturer Narrative

H6: eval code method (fdm/annex b), updated code.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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19175211
• MDR Text Key: 340955555
• Report Number: 9617601-2024-00069
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/26/2024
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male