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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problem ST Segment Elevation (2059)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed that 7 injections were performed with a balloon catheter without any issues or system notices.Visual inspection of the sheath showed that the shaft was kinked 2.5 inches from the tip.Functional testing of the sheath confirmed that the hemostatic valve was leaking, and air bubbles were observed through the valve.A torn valve disk was suspected.In conclusion, the reported air ingress issue was confirmed through testing.The reported st elevation could not be confirmed through testing or data analysis.The sheath failed the returned product inspection due to a leaking hemostatic valve and shaft kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, upon inserting the sheath into the left atrium and as aspiration and flush were performed, st elevation occurred.Medications were administered, and coronary angiography was performed.Air was not observed.The st elevation recovered, and the case was completed with cryo.It was noted that air ingress was suspected.No further 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: 7404832
• MDR Text Key: 104656590
• Report Number: 3002648230-2018-00204
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 93255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2017
• 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
• Patient Outcome(s): Required Intervention