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

Model Number 106A3

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The files showed system notice #50012 ¿the refrigerant delivery path is obstructed¿ in application 15 and system notice #50011 ¿the refrigerant delivery path is obstructed¿ in the beginning of the applications 17, 18 and 19 with balloon catheter afapro28 with lot number 57857.The files showed at least 20 applications were performed with this catheter on the date of the event.The files also confirmed system notice #50011 ¿the refrigerant delivery path is obstructed¿ in applications 1, 4 ,5 ,6, 7,8 and 10 with balloon catheter afapro28 with lot number 57855.The files showed at least 10 applications were performed with this catheter on the date of the event.The product issues reported (system notice 50011, 50012, and pressure issues) are 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, system notices were received indicating that the refrigerant delivery path was obstructed.The coaxial umbilical cable and balloon catheter were replaced without resolve.The coaxial port was examined, and no debris or broken tip was observed.The tank was replaced and the console vented, without resolve.The coaxial umbilical cable was replaced again and the console was rebooted.No flow was noted, and the pressure was different than expected.The case was aborted with the patient under general anesthesia.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the console part (mks valve) was returned and analyzed.Visual inspection showed that it was intact with no apparent issues.The console was tested with a test catheter and the pressure issues were reproduced.The full console unit was not returned for investigation and still in use after the returned part was replaced.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 9708387
• MDR Text Key: 185943459
• Report Number: 3002648230-2020-00089
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169449596
• UDI-Public: 00643169449596
• Combination Product (y/n): N
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other