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

Model Number 4FC12

Device Problems Fluid/Blood Leak (1250); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least four injections were performed with catheter 2af284 / 17118-53 on the date of the event without any triggered system notice, data files also showed at least another seven injections were performed with catheter 2af284 / 99242-49 on the date of the event without triggered any system notice.The failure file showed the following system notices have been triggered on the date of the event: #50011 ¿the refrigerant delivery path is obstructed¿; #50012 ¿the refrigerant delivery path is obstructed¿; #50034 ¿the safety system has detected a compromised outer vacuum¿; #50007 ¿the safety system has detected fluid in the console.The system is inoperable¿; #50008 ¿the system has detected a software error and stopped the injection;¿ #50009 ¿the system has detected a failure¿; #50013 ¿the refrigerant level is too low to continue¿; #50014 ¿the balloon is not sufficiently inflated; balloon inflation pressure was not reached in time¿; #50017 ¿the operational temperature of the system is high preventing proper operation¿.#50035 ¿the balloon is deflated¿; #12222 ¿the system detected a refrigerant leak during balloon inflation¿.Upon visual inspection of flexcath sheath 4fc12 / 92497-088, results showed the shaft was kinked 60 mm from the tip.Air aspiration was reproduced when a lab test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported air ingress issue was confirmed through testing but not confirmed through the data analysis.The sheath failed the returned product inspection due to a kink at shaft and a leaking hemostatic valve.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, after the balloon catheter was inserted into the sheath, air was continuously introduced during aspiration.The issue persisted when air aspiration was performed again.The sheath was replaced without resolve.The balloon catheter was replaced with resolve.The physician suspected that the balloon catheter was larger than normal.The case was completed with cryo.No patient complications have been reported as a result of this event.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6825477
• MDR Text Key: 86293727
• Report Number: 3002648230-2017-00467
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 92497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2017
• 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