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 01/24/2017

Event Type  malfunction  

Event Description

It was reported that during a cryoablation procedure, air was leaking.The balloon catheter was re-inserted without resolve.Then the sheath was replaced and the procedure continued.After the sheath was replaced, micro bubbles were observed inside the side port.Aspiration was performed several times, but the microbubbles were still observed.The sheath was replaced again and the procedure was continued.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Data files were returned and analyzed.Data files showed did not confirm any issues with the sheath.In conclusion, the reported issue could not be confirmed through data files.Device investigation still in progress.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.

Manufacturer Narrative

Product event summary: the device were returned and analyzed.Visual inspection of the sheath showed that the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.A dissection showed that the hemostatic valve was leaking on the sheath.In conclusion, air ingress was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.

Manufacturer Narrative

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: 6336526
• MDR Text Key: 67606026
• Report Number: 3002648230-2017-00076
• 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,Followup,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 31031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2016
• 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
• Treatment: 4FC12 SHEATH