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

Model Number 4FC12

Device Problem Kinked (1339)

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

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the reported event and the sheath, 4fc12 with lot 24628, were returned and analyzed.The data files showed two unrelated system notices for the date of the event.The data files also showed flow and temperature problems, and showed non-sustained applications.Visual inspection of the sheath showed that the shaft kinked at 65 millimeters from the tip, and connection shaft/handle.Deflection did not work as expected due to this kink.The reported issue has been confirmed through testing.In conclusion, the sheath, 4fc12 with lot 24628, failed the inspection due to a shaft kink near the tip.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 safety system detected a compromised outer vacuum.Additionally, steerability issues were observed when using the sheath.The sheath and balloon catheter were replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.The sheath was returned to the manufacturer, analyzed, and tested out of specification.

• 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: 7260839
• MDR Text Key: 99924860
• Report Number: 3002648230-2018-00084
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2018

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: 05/19/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 24628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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