MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA CARDIAC CRYOABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 217F3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Asystole (4442); Heart Block (4444)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Continuation from d10: 217f3 electrophysiology (ep) catheter product event summary: the data files were returned and analyzed.The received failure file did not contain any failure records for the date of the event.No patient date file was received.In conclusion, the clinical issues for asystole and heart block occurred during the procedure and could not be assessed through data file analysis.The clinical issue for phrenic nerve issue occurred during the procedure.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment 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.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the catheter may be outside the patient.The electrophysiology (ep) catheter was replaced to resolve the system  notice.After replacement temperatures were not as expected and the new electrophysiology (ep) catheter did not pass the system flush.The electrophysiology (ep) catheter was pulled into the sheath to resolve the issue.Later, it was noted that an 'asystolic event' occurred that was further described with a heart block that was caused by normal catheter manipulation near the his bundle via the aorta.Ablation was decided to not be performed due to the patient's reaction and length of time that had been attempted to find the area of interest.Catheter pacing was performed and titrated.The transient heart block returned after catheter stimulation.The case was aborted.The patient was under general anesthesia. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Updated h6: eval code method (fdm/annex b).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.

Event Description

It was later reported that the 'asystolic event' was transient heart block that returned after catheter stimulation.This was confirmed by the recording system showed atrial electrical activity but no ventricular activity.The catheter pacing carried out was confirmed to be electrical stimulation from a coronary sinus catheter.The procedure was aborted after the transient heart block occurred and during access via arterial groin to the aortic cusp to assess left sided pathway.

Manufacturer Narrative

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: FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18536689
• MDR Text Key: 333156024
• Report Number: 3002648230-2024-00015
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000542108
• UDI-Public: 00763000542108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 217F3
• Device Catalogue Number: 217F3
• Device Lot Number: 37123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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): Required Intervention; Other; Life Threatening