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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Material Twisted/Bent (2981)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a cryoablation procedure, air was continuously drawn through the sheath.The patient¿s st segments became elevated, and a spasm occurred.After administration of nitroglycerin, the issue was resolved.The sheath was replaced but the case was aborted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files and 4fc12 sheath with lot 0010546714 was returned and analyzed.The files confirmed system notice 50032 ¿the safety system has detected a compromised outer vacuum¿ in applications 7 through 10 and applications 11 and 12 with a returned balloon catheter.The files showed at least 10 applications were performed with this catheter on the date of the event.The application #11 was performed with a non-returned balloon catheter without any issue.Visual inspection showed the device shaft was kinked and twisted at around 1.49 inches from tip.Using the sentinel blackbelt leak tester, the sheath passed the test and showed the shaft and valve were leak tight with no apparent issue.Aspiration and flush testing did not show any air passing through the tube or expelled from the sheath distal tip.The hemostatic valve was leak tight.Deflection also worked as per specification.The clinical issues (st elevation, coronary artery spasm/vasospasm) occurred during the procedure.The reported clinical issues cannot be assessed through testing.In conclusion, the reported air ingress issue was not confirmed through testing.However, the sheath failed the returned product inspection due to a shaft kink and twist.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
• MDR Report Key: 11893892
• MDR Text Key: 252934497
• Report Number: 3002648230-2021-00267
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010546714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention