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

Model Number 4FC12

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: data files were returned and analyzed.Data files showed that at 10 applications were performed with two balloon catheters on the date of the event with no system issue.Failure files confirmed a system notice occurred indicating a catheter electrical connection failure on the date of the event.Visual inspection of the sheath showed that the device was intact with no apparent issues.Flush testing did not show any air passing through the tube or expelled from the distal tip.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Functional testing of the sheath confirmed that the hemostatic valve was leaking.Air bubbles were observed through the valve.We suspect the valve disk is torn.In conclusion, the reported air ingress during aspiration was confirmed through testing but not confirmed through data analysis.The reported issue system notices ((b)(4)) and ((b)(4)) was not confirmed through the testing but confirmed through the data analysis.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a cryo ablation procedure, the push button was not as expected, and upon inserting the balloon catheter into the sheath, air was being aspirated through the side port of the sheath, when negative pressure was applied.The sheath was replaced without resolve.The balloon catheter was then replaced with resolve.The case was completed with cryo.The sheath subsequently tested out of specification upon the manufacturer's analysis.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: 7430656
• MDR Text Key: 105526606
• Report Number: 3002648230-2018-00223
• 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: 04/13/2018

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: 11/10/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 64406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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 Age: 68 YR