MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 106A3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least seven applications were performed with the returned balloon catheter afapro28 with lot number 22249, on the date of the event.System notice 50024 ¿vent system failure¿ and 50005 ¿leak detection¿ were confirmed after the use of this catheter.The product issue reported system notice 50024 is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that there was a problem with the refrigerant port.The coaxial umbilical cable was checked for moisture and the console was rebooted with everything disconnected, without resolve.A hissing noise was noted from the console port.A system notice was received as well indicating that there is a problem with the system.The case was aborted with the patient under general anesthesia.The pressure was different than expected as well.A field service visit was recommended.No further patient complications have been reported as a result of this event.A field service visit was performed at a later date.The tank was opened and the high pressure regulator (hpr) was observed to be leaking significantly.The hpr was tightened and the leak stopped.Test injections were performed and a slight leak was noticed from the blood bottle.The blood bottle and tubing connections near the blood bottle were tightened, as well as other connections.No further leaks were observed, and the console was serviced.

• Brand Name: CRYOCONSOLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9674035
• MDR Text Key: 185942261
• Report Number: 3002648230-2020-00069
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: 00763000011147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other