MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/14/2023

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, after complete right inferior pulmonary vein (ripv) ablation and some right superior pulmonary vein (rspv) ablation, a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced which resolved the issue.After three freezes in the rspv and two freezes in the left superior pulmonary vein (lspv), the patient's blood pressure dropped lower than expected.A pericardial effusion was noted on intracardiac echocardiography (ice).The procedure was aborted while the patient was under general anesthesia.The patient's chest was then prepped and accessed; blood was aspirated from the pericardium.The patient was then stabilized and transferred to the operating room where a tear was found on the right carina in the left atrium, between the lspv and left inferior pulmonary vein (lipv).The tear was repaired and the patient was transferred to the intensive care unit (icu) for overnight hospitalization.The patient remains in the icu, is stable, and is "doing well." 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: afapro28, product type: balloon catheter, product id: 4fc12, product type: sheath product id: 990063-015, product type: mapping catheter.Product event summary: the data file was returned and analyzed.One patient file was received and recorded on the reported date of the event.The received patient file showed six applications were performed using the first afapro28 balloon catheter with lot number 12118.The patient file showed nine applications were performed using a second afapro28 balloon catheter with lot number 12104.The patient file showed system notice 50032 (the safety system has detected a compromised outer vacuum) during ablation at application number five while the first balloon catheter was in use.In conclusion, the clinical issues (pericardial effusion, atrial tear, and hypotension) occurred during the procedure with no indication that the adverse events were related to the performance or a malfunction of the product and the decision to abort the procedure without use of alternate therapy was based upon the medical judgement of the physician.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.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18583034
• MDR Text Key: 333773316
• Report Number: 3002648230-2024-00023
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0012002503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• 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: SEE H10...
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 102 KG