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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438)

Event Date 01/27/2022

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, when the sheath was placed in the left atrium and the dilator removed, the patient's blood pressure fell, and cardiac arrest occurred.Coronary sinus distal pacing was performed.It was noted that st elevation occurred immediately before the cardiac arrest and air embolism was suspected.A coronary angiogram was performed; multiple air bubbles were confirmed through right coronary imaging.When the air bubbles were suctioned, the patient's heartbeat resumed, and the blood pressure stabilized.Further ablation was considered a risk and the procedure was aborted.The following day patient recovery was observed.The patient hospitalization was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient codes (fdp, ime) updated to reflect the more specific codes for air embolism.Product event summary: the 4fc12 sheath was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.The handle, shaft and sideport were intact with no apparent issue.The functional testing was performed and no anomaly was discovered.Compatibility tests with a balloon catheter and dilator passed.The performance test with sentinel blackbelt leak tester was performed.1- the pressure test with 30 psig passed.2- the flushing test with 6 psig passed.3- the aspiration test with negative pressure of 4.1 psig passed.All the performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issue.In conclusion, the reported blood pressure decrease, st elevation, air embolism, and cardiac arrest were clinical issues that occurred during the procedure and the sheath passed 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.

• 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, MN ; EI ; 7635055378
• MDR Report Key: 13584415
• MDR Text Key: 285995454
• Report Number: 3002648230-2022-00066
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010925109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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): Life Threatening; Hospitalization