MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 217F3

Device Problem Break (1069)

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

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the electrophysiology (ep) catheter and data files were returned and analyzed.The data files confirmed the system notice that indicated that the injection was stopped because the cryomapping temperature exceeded the preset value by more than fifteen degrees (b)(4) and the system notice indicating that the safety system detected a high level of refrigerant flow and stopped the injection (b)(4).Visual inspection of the catheter showed that the shaft of the catheter was broken 1.2 inches from the strain relief.The catheter failed the performance test due to a broken/snapped shaft.There were no traces of blood, and no patient complications.Also, the shaft material was brittle and uv sensitive when exposed for a long period of time to the light.In conclusion, the reported issue was confirmed through testing and data analysis.The catheter failed inspection due to a shaft breakage/snapping.

Event Description

It was reported that during a cryo ablation procedure, a system notice had occurred indicating that the injection was stopped because the cryomapping temperature exceeded the preset value by more than fifteen degrees.Also, there was temperature issues and an indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The electrophysiology (ep) catheter was replaced and the procedure was completed with the console.The device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5587539
• MDR Text Key: 43017517
• Report Number: 3002648230-2016-00152
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P020045
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: 217F3
• Device Catalogue Number: 217F3
• Device Lot Number: 01763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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: 00015 YR
• Patient Weight: 65