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 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least 22 applications were performed with balloon catheter, 2af284 with lot number 30970.Also, it confirmed a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The product issue reported, a system notice was received indicating that the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped 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 cryoablation procedure, a system notice was received indicating that the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped.The case was aborted with the patient under general anesthesia.A field service visit was completed on a later date.Pressure overshoots were observed and a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The injection proportion valve was replaced to address the pressure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the console part(injection proportional valve) was returned and inspected.Visual inspection showed that the product was intact with no apparent issues.The part was assembled to the console and following a warm up time of 30 minutes, the performance test was completed without any system notice triggered.On a cooling performance test, the console failed the test and could not reach the required pressure of 500 and 750 ± 5 psig in a controlled way.In conclusion, the product issue reported, a system notice was received indicating that the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped is not likely to cause or contribute to a death or serious injury.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: 8795601
• MDR Text Key: 151203173
• Report Number: 3002648230-2019-00506
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169352476
• UDI-Public: 00643169352476
• 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: 02/12/2020

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: 01/10/2020
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other