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 Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/14/2022

Event Type  Death  

Event Description

It was reported that during a cryo ablation procedure, the physician felt the balloon "push back" during a transition off ablation.Then, the patient's hemodynamics changed.A pericardiocentesis was performed.The procedure was aborted with the patient under general anesthesia and the patient was transported to the operating room.A tear was discovered in the left superior pulmonary vein (lspv).The tear was difficult to repair due to fragile tissue.The patient died the following day.

Manufacturer Narrative

Product event summary: the data files and mapping catheter 2ach20 with lot number 7178206 was returned and analyzed.The files showed at least four applications were performed with the returned balloon catheter without any issue on the date of the event.The mapping catheter was received inserted inside the balloon catheter.Unable to retract the achieve mapping catheter, possibly due to the blood inside the balloon catheter shaft being coagulated.The functional test was performed.The mapping catheter was connected to the diagnostic computer (prucka) using the test mapping catheter cable.All the channel pairs were not displaying any noise.Movement and deflection of the catheter distal to the lemo connector did not induce any interference noise.No anomalies were identified.In conclusion, the reported clinical issues, pericardial effusion and tissue damage, occurred during the procedure.There is no indication of a relationship of the adverse events to the performance or malfunction of the products.The mapping catheter did not fail the returned product inspection.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This additional information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.Referenced article: catastrophic left atrial tear during cryoballoon pulmonary vein isolation following chemotherapy.Heart rhythm case reports.2023; 9:482¿485.Doi: 10.1016/j.Hrcr.2023.04.015.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was further reported via literature that approximately 30 seconds into cryoablation, after the "push back" there was an appearance of a large pericardial effusion on intracardiac echocardiography.The ablation was immediately stopped and cardiopulmonary resuscitation was initiated.Despite repair of the tear, the patient developed a profound coagulopathy and persistent right ventricular failure necessitating placement on extracorporeal membrane oxygenation.

• 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: 15779202
• MDR Text Key: 303533443
• Report Number: 2182208-2022-03639
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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: 7178206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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
• Treatment: BALLOON CATHETER AFAPRO28
• Patient Outcome(s): Death; Other; Required Intervention; Life Threatening
• Patient Sex: Female