MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYO-UNKNOWN; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number CRYO-UNKNOWN

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170); Device Displays Incorrect Message (2591)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).

Event Description

It was reported that during a cryoablation procedure, a system notice was received indicating that there is a problem with the system.Additionally, a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable and a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The healthcare professional had replaced the catheter, coaxial umbilical, electrical umbilical, auto connection box, and rebooted without resolve.There appeared to be a blood leak in the catheter.The catheter was not inside the patient at the time.The healthcare professional was using re-sterilized cables.It was recommended to change out the cables.The radiofrequency generator was turned off and the issue did not re-occur.

Manufacturer Narrative

Product event summary: data files nor product were provided for analysis.Power-up code analysis was performed.The issue was resolved on site upon changing out the re-sterilized cables and radiofrequency generator was turned off.In conclusion, this was a generator and re-sterilized cables related issue resolved on site.Neither bin files nor product was returned for analysis.

• Brand Name: CRYO-UNKNOWN
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5183065
• MDR Text Key: 30210704
• Report Number: 3002648230-2015-00380
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRYO-UNKNOWN
• Device Catalogue Number: CRYO-UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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