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

Model Number 4FC12

Device Problem Air Leak (1008)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

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, upon insertion of the balloon catheter into the sheath, it was observed that only the balloon part could be inserted, and the catheter was unable to be advanced further.The balloon catheter was removed, with the release vacuum on the console screen pressed, and the catheter was reinserted, with no resolve.The catheter was then replaced, and it was observed that air in the side port of the sheath was not aspirated completely.The sheath was replaced with resolve.The procedure continued, and a system notice was received indicating that the refrigerant delivery path was obstructed.The coaxial umbilical cable was then reconnected, and the case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot 48878, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a lab test balloon catheter was introduced through the sheath.The leak test at the hemostasis valve was performed to simulate the pressure test during the manufacture product inspection.Air bubbles were observed through the hemostasis valve.The torn valve disk is suspected, which can contribute the leakage.In conclusion, the reported air ingress during aspiration issue was confirmed through testing.The sheath, 4fc12 with lot 48878, failed the performance test due to the leakage on the hemostatic valve.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
• 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: 6897642
• MDR Text Key: 87862604
• Report Number: 3002648230-2017-00538
• 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,Followup
• Report Date: 11/13/2017

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: 06/01/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 48878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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